(188 days)
K011623, K031730, K110290, K121308, K041170, K051738, K022555, K121308, K994366, K020572, K994366, K023102, K051741, K121308, K103479, K120578, K143085, K122853, K143085, K123604, K143085, K031744, K983226, K013676, K143085, K081171, K143085, K142462, K151264, K010170, K143085, K983502, K983382, K143085, K040412, K072020, K102019, K920868, K942809, K103233, K093644, K072020, K033716, K061434, K062419, K983502, K991952, K021911, K020497, K061654, P960047, K983502, K052718, K070885, K041940, K051588, K993601, K010757, K022077, K061434, K900836, K993601, K021310, K910988, K061434, K121308, K023901, K971409, K003391, K991952, K902365, K014226, K954077, K992570, K121308, K003379, K051737, K070885, K894124, K943549, K903362, K914406
Not Found
No
The summary describes various hip arthroplasty components and their indications for use. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The focus is on the physical components and their compatibility with MR environments.
Yes
The devices are designed for hip arthroplasty to treat painful and disabling joint diseases, fractures, and other conditions that restore function and relieve pain.
No.
This device is a hip implant system, which is a prosthetic device used to replace a damaged hip joint, not to diagnose a condition. The "Indications for Use" section clearly lists conditions the device is used to treat, such as "Painful, disabling joint disease of the hip," rather than to diagnose them.
No
The device description and intended use clearly describe physical hip implants (shells, stems, heads, liners, screws, etc.) used in hip arthroplasty. The submission is for labeling modifications related to MR compatibility and contraindications for these physical devices, not for a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The descriptions clearly state that these devices are intended for use in primary or revision hip arthroplasty. This involves surgical implantation to replace or repair a damaged hip joint.
- Device Description: The devices are described as passive implants and components of a total hip prosthesis. These are physical devices implanted into the body.
- Performance Studies: The performance studies focus on the MR compatibility of the implants, which is relevant to implanted medical devices, not IVDs.
- Anatomical Site: The anatomical site is the Hip, indicating a device used within the body.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The devices described here are implanted medical devices used for surgical treatment.
N/A
Intended Use / Indications for Use
Trident PSL Shell, Trident Tritanium Shell, Trident Hemispherical Shell
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Trident shells are intended for cementless fixation within the prepared acetabulum.
Tritanium Acetabular Shell System
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Tritanium Acetabular Shell System is intended for cementless use only.
Accolade II Femoral Stem, Secur-Fit Advanced Femoral Stem, Anato Femoral Stem
The indications for use for total hip arthroplasty with stems include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners: - When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade II, Secur-Fit Advanced and Anato Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty.
Exeter® V40TM Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Hip System is intended for use in total hip replacement. It is intended for cemented use only.
The Exeter® Hip is indicated for:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis:
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Restoration Anatomic Shell
Indications for Use
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
When used with Constrained Liner: - The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.
Omnifit HFX Femoral Stems
Indications:
For use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
- Femoral neck fractures.
For use as a Total Hip Replacement: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.
Omnifit EON Cemented Femoral Stems
Indications
For use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
For use as a Total Hip Replacement: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Secur-Fit Max and Secur-Fit Max Plus Hip Stems
Secur-Fit Max and Secur-Fit Max Plus Hip stems are single use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
Indications for use as a Total Hip Replacement include:
- noninflammatory degenerative joint disease. including osteoarthritis and avascular necrosis:
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Accolade C Femoral Stems
The Accolade C Femoral Stems are single-use devices intended for cemented fixation.
Indications for use as a Total Hip Replacement include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Accolade HFx Femoral Stems
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis:
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Accolade TMZF and Accolade TMZF Plus Femoral Stems
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed.
Restoration Acetabular Wedge Augments
The indications for use of the Restoration Acetabular Wedge Augments:
General Indications for Total Hip Replacement Components:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications Specific to the Acetabular Wedges: - As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.
Acetabular Augments are intended for cementless use only to the bone interface, and are affixed to the mating cup using bone cement
Trident AD Acetabular shells
The Trident AD Acetabular shells are single use devices. The shell is intended for cemented or cementless fixation within the prepared acetabulum. The Trident AD Acetabular Component System is compatible with any appropriately selected Howmedica Osteonics hip stem/femoral head combination.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Trident T Acetabular shells
The Trident Acetabular shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.
General Indications for Total Hip Replacement Components:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Restoration ADM System, Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert
The indications for use of the total hip arthroplasty prostheses include:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks.
These devices are intended for cementless use only
Acetabular Dome Hole Plug
The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the acetabular cup. The Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell.
Indications
- In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.
Trident X3, Trident Crossfire, Trident X2Vac and Trident X3/Crossfire Elevated Rim Acetabular Liners
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Trident® Constrained Acetabular Insert
The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
BIOLOX Delta Ceramic Heads (C-Taper, Universal Taper, V40 to Universal Taper Adapter Sleeve, and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
For Use as a Bipolar Hip Replacement - Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty
V40 BIOLOX Delta Ceramic Heads
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement - Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-. rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other considerations:
- Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty
Alumina C-Taper Ceramic Heads
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement - Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
Alumina V40 Ceramic Heads
- Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
- Rheumatoid arthritis
- Correction of functional deformity
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by the deficiencies of the acetabulum;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques;
- Revision procedures where other treatments or devices have failed.
C-Taper CoCr Femoral Heads (LFIT and non-LFIT)
For use as a Bipolar Hip Replacement:
-
- Femoral head/neck fractures or non-unions
-
- Aseptic necrosis of the femoral head.
-
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
-
- Pathological conditions or age considerations which indicate a more conservative approach to the acetabulum and the avoidance of the use of bone cement in the acetabulum.
-
- Salvage of failed total hip arthroplasty.
Indications for use as part of a Total Hip Replacement include:
- Salvage of failed total hip arthroplasty.
-
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
-
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
-
- Clinical management situations where arthrodesis or alternate reconstructive techniques are less likely to achieve satisfactory results.
V40 CoCr Femoral Heads (LFIT and non-LFIT)
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Unitrax Endoprosthesis, Unitrax V40 Adapter Sleeve, Unitrax C-Taper Adapter Sleeve
- The Howmedica Osteonics Unitrax Endoprosthesis, and the Unitrax V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and non-unions. The Unitrax C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or non-unions, aseptic necrosis of the femoral head/neck and osteo- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis.
Universal Distal Spacer
Howmedica Osteonics Corp.'s accessory products for cemented arthroplasty are optional devices intended to assist in the preparation, implantation and/or positioning of a femoral implant intended for cemented application.
Indications
For cement spacers, mid-shaft restrictors and Cement Plugs:
- In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.
Torx Screws, GAP Plate Screws and Osteolock Bone Screws
- Howmedica Osteonics Torx Cancellous Bone Screws are intended for supplemental fixation of associated Howmedica Osteonics cementless Acetabular Shells or Howmedica Osteonics Tibial Tray components.
- Howmedica Osteonics Osteolock Bone Screws are intended for supplemental fixation of associated cementless Trident Tritanium Multihole Acetabular shells, Restoration Acetabular Augments, and Restoration Anatomic Shell.
- Howmedica Osteonics Restoration GAP Plate Screws are intended only for fixation of the dome and iliac plates of the associated Howmedica Osteonics Restoration GAP Acetabular Shells, Trident Tritanium Hemispherical Multihole Acetabular Shells, Restoration Acetabular Augments and Restoration Anatomic Shell.
V40 to C-Taper Adapter Sleeve For Use as a Total Hip Replacement
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement - Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LPH, KWZ, LZO, MAY, MEH, JDI, KWL, LWJ, KWY, HWC, MBL
Device Description
All of the subject devices have been found substantially equivalent in previous premarket indications. The purpose of this submission is to modify the labeling to add MR compatibility to the labeling for the devices indicated above, and to remove a contraindication for selected devices. There have been no changes made to the devices requiring 510(k) clearance - only the labeling is being modified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence: Non-clinical testing as outlined in the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and FDA Staff", dated December 11, 2014 was conducted to characterize the compatibility of Stryker Orthopaedics total hip passive implants in the MR environment. FDA draft guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance for Industry and FDA Staff", dated June 29, 2015 was also consulted for the heating evaluations performed. Testing was performed according to the standards listed below:
- Magnetically Induced Displacement Force performed per ASTM F2052-06 and ASTM F2052-14, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment
- Magnetically Induced Torque - performed per ASTM F2213-06 (Reapproved 2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment
- Image Artifact performed per ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- Heating by RF Fields per ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating near Passive Implants during MR Imaging
The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned. Additionally, for certain devices, a contraindication was removed.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011623, K031730, K110290, K121308, K041170, K051738, K022555, K121308, K994366, K020572, K994366, K023102, K051741, K121308, K103479, K120578, K143085, K122853, K143085, K123604, K143085, K031744, K983226, K013676, K143085, K081171, K143085, K142462, K151264, K010170, K143085, K983502, K983382, K143085, K040412, K072020, K102019, K920868, K942809, K103233, K093644, K072020, K033716, K061434, K062419, K983502, K991952, K021911, K020497, K061654, P960047, K983502, K052718, K070885, K041940, K051588, K993601, K010757, K022077, K061434, K900836, K993601, K021310, K910988, K061434, K121308, K023901, K971409, K003391, K991952, K902365, K014226, K954077, K992570, K121308, K003379, K051737, K070885, K894124, K943549, K903362, K914406
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected. The profiles are rendered in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
Stryker Orthopaedics Ms. Margaret Klippel Principal Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K153345 Trade/Device Name: Stryker Orthopaedics Total Hip Systems Labeling Update Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: Class II Product Code: LPH, KWZ, LZO, MAY, MEH, JDI, KWL, LWJ, KWY, HWC, MBL Dated: April 20, 2016 Received: April 22, 2016
Dear Ms. Klippel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Trident PSL Shell, Trident Tritanium Shell, Trident Hemispherical Shell
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- o Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques ● are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Trident shells are intended for cementless fixation within the prepared acetabulum.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Tritanium Acetabular Shell System
- . Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques ● are less likely to achieve satisfactory results.
- . Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Tritanium Acetabular Shell System is intended for cementless use only.
Over-The-Counter Use Prescription Use AND/OR X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Accolade II Femoral Stem, Secur-Fit Advanced Femoral Stem, Anato Femoral Stem
The indications for use for total hip arthroplasty with stems include:
- . noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners. ● the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade II, Secur-Fit Advanced and Anato Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
5
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Exeter® V40™ Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Hip System is intended for use in total hip replacement. It is intended for cemented use only.
The Exeter® Hip is indicated for:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular ● necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
6
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Restoration Anatomic Shell
Indications for Use
- . Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.
When used with MDM Liners
- o Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks ●
When used with Constrained Liner:
- The Trident Constrained Acetabular Insert is indicated for use in primary and revision o patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
7
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Omnifit HFX Femoral Stems
Indications:
For use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head. ●
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
- Femoral neck fractures.
For use as a Total Hip Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
- Clinical circumstances which require an altered femoral resection level due to a proximal o fracture, bone loss or calcar lysis.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
8
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Omnifit EON Cemented Femoral Stems
Indications
For use as a Bipolar Hip Replacement:
- . Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head. ●
- o Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty. ●
For use as a Total Hip Replacement:
- o Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
9
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Secur-Fit Max and Secur-Fit Max Plus Hip Stems
Secur-Fit Max and Secur-Fit Max Plus Hip stems are single use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
Indications for use as a Total Hip Replacement include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular ● necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
10
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Accolade C Femoral Stems
The Accolade C Femoral Stems are single-use devices intended for cemented fixation.
Indications for use as a Total Hip Replacement include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity; ●
- revision procedures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
11
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Accolade HFx Femoral Stems
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
12
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Accolade TMZF and Accolade TMZF Plus Femoral Stems
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
13
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Restoration Acetabular Wedge Augments
Indications for Use:
The indications for use of the Restoration Acetabular Wedge Augments:
General Indications for Total Hip Replacement Components:
- . Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications Specific to the Acetabular Wedges:
- As an alternative to structural allograft in cases of superior and superior/posterior segmental o acetabular deficiencies.
Acetabular Augments are intended for cementless use only to the bone interface, and are affixed to the mating cup using bone cement
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
14
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Trident AD Acetabular shells
Indications for Use:
The Trident AD Acetabular shells are single use devices. The shell is intended for cemented or cementless fixation within the prepared acetabulum. The Trident AD Acetabular Component System is compatible with any appropriately selected Howmedica Osteonics hip stemoral head combination.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
15
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Trident T Acetabular shells
Indications for Use:
The Trident Acetabular shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.
General Indications for Total Hip Replacement Components:
- o Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
16
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Restoration ADM System, Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert
Indications for Use:
The indications for use of the total hip arthroplasty prostheses include:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed:
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
- . Dislocation risks.
These devices are intended for cementless use only
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
17
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Acetabular Dome Hole Plug
The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the acetabular cup. The Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell.
Indications
- . In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
18
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Trident X3, Trident Crossfire, Trident N2Vac and Trident X3/Crossfire Elevated Rim Acetabular Liners
Indications for Use:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
- . Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
19
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Trident® Constrained Acetabular Insert
Indications for Use:
The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
20
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
BIOLOX Delta Ceramic Heads (C-Taper, Universal Taper, V40 to Universal Taper Adapter Sleeve, and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head. ●
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular ● involvement or distortion.
- Pathological considerations or age considerations which indicate a more conservative ● acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty ●
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
21
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
V40 BIOLOX Delta Ceramic Heads
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular o involvement or distortion.
Other considerations:
- Pathological considerations or age considerations which indicate a more conservative ● acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- o Salvage of failed total hip arthroplasty
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
22
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Alumina C-Taper Ceramic Heads
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head. ●
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative ● acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
23
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Alumina V40 Ceramic Heads
Indications:
- Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
- Rheumatoid arthritis ●
- Correction of functional deformity
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by the deficiencies of the acetabulum;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques;
- Revision procedures where other treatments or devices have failed.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
24
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
C-Taper CoCr Femoral Heads (LFIT and non-LFIT)
For use as a Bipolar Hip Replacement:
- l. Femoral head/neck fractures or non-unions
-
- Aseptic necrosis of the femoral head.
-
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative 1. approach to the acetabulum and the avoidance of the use of bone cement in the acetabulum.
-
- Salvage of failed total hip arthroplasty.
Indications for use as part of a Total Hip Replacement include:
- l. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
-
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
-
- Clinical management situations where arthrodesis or alternate reconstructive techniques are less likely to achieve satisfactory results.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
25
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
V40 CoCr Femoral Heads (LFIT and non-LFIT)
Indications for Use:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
- Rheumatoid arthritis
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed
- o Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
26
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Unitrax Endoprosthesis, Unitrax V40 Adapter Sleeve, Unitrax C-Taper Adapter Sleeve
The Howmedica Osteonics Unitrax Endoprosthesis, and the Unitrax V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and non-unions. The Unitrax C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or non-unions, aseptic necrosis of the femoral head/neck and osteo- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
27
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Universal Distal Spacer
Howmedica Osteonics Corp.'s accessory products for cemented arthroplasty are optional devices intended to assist in the preparation, implantation and/or positioning of a femoral implant intended for cemented application.
Indications
For cement spacers, mid-shaft restrictors and Cement Plugs:
- In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be . advantageous.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
28
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
Torx Screws, GAP Plate Screws and Osteolock Bone Screws
- Howmedica Osteonics Torx Cancellous Bone Screws are intended for supplemental fixation ● of associated Howmedica Osteonics cementless Acetabular Shells or Howmedica Osteonics Tibial Tray components.
- Howmedica Osteonics Osteolock Bone Screws are intended for supplemental fixation of ● associated cementless Trident Tritanium Multihole Acetabular shells, Restoration Acetabular Augments, and Restoration Anatomic Shell.
- Howmedica Osteonics Restoration GAP Plate Screws are intended only for fixation of the ● dome and iliac plates of the associated Howmedica Osteonics Restoration GAP Acetabular Shells, Trident Tritanium Hemispherical Multihole Acetabular Shells, Restoration Acetabular Augments and Restoration Anatomic Shell.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
29
510(k) Number (if known): K153345
Device Name: Stryker Orthopaedics Total Hip System Labeling Update
V40 to C-Taper Adapter Sleeve
For Use as a Total Hip Replacement
- Painful disabling joint disease of the hip resulting from: degenerative arthritis. o rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular ● involvement or distortion.
Other Considerations:
- . Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty. ●
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
30
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Margaret Klippel
Senior Regulatory Affairs Project Manager
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
Telephone: 201-831-5559
Fax: 201-831-4559 |
| Alternate Contact | Patricia Setti-LaPerch
Manager, Regulatory Affairs
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
Telephone: 201-831-5938
Fax: 201-831-4938 |
| Date Prepared: | May 24, 2016 |
| Proprietary Name: | Stryker Orthopaedics Total Hip Systems Labeling Update |
| Common Name: | Artificial Hip Replacement Components -- Acetabular and Femoral |
| Classification Name:
And References: | Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis 21 CFR §888.3358 |
| | Hip joint metal/polymer constrained cemented
or uncemented prosthesis 21 CFR §888.3310 |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis 21 CFR §888.3353 |
| | Hip joint metal/polymer semi-constrained cemented prosthesis 21
CFR §888.3350 |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis 21 CFR §888.3360 |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis 21 CFR §888.3390 |
| | Smooth or threaded metallic bone fixation fastener 21 CFR
§888.3040 |
| Product Codes: | LPH - prosthesis, hip, semi-constrained, metal/polymer, porous
uncemented
KWZ - prosthesis, hip, constrained, cemented or uncemented,
metal/polymer
LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous, uncemented
MEH - prosthesis, hip, semi-constrained, uncemented,
metal/polymer, non-porous
JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented
LWJ - prosthesis, hip, semi-constrained, metal/polymer, |
| | uncemented
KWL - prosthesis, hip, hemi-, femoral, metal
KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented
or uncemented
MAY - prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous cemented, osteophilic finish
MBL-prosthesis, hip, semi-constrained, uncemented,
metal/polymer, porous
HWC - screw fixation bone |
31
Legally Marketed Device to Which Substantial Equivalence is Claimed:
| Femoral Stems | |
|---|---|
| Exeter Femoral Stems (V40 taper – | |
| includes Orthinox femoral heads) | K011623, K031730, K110290, |
| K121308 | |
| SecurFit Max Femoral Stems | K041170, K051738 |
| SecurFit Max Plus Femoral Stems | |
| Accolade C Femoral Stems | K022555, K121308 |
| Accolade TMZF Femoral Stems | K994366, K020572 |
| Accolade TMZF Plus Femoral Stem | K994366, K023102 |
| Accolade HFx Femoral Stem | K051741, K121308 |
| Accolade II Femoral Stems | K103479, K120578, K143085 |
| SecurFit Advanced Femoral Stems | K122853, K143085 |
| Anato Femoral Stems | K123604, K143085 |
| OmniFit HFx Femoral Stems | K031744 |
| OmniFit EON Femoral Stems | K983226 |
| Acetabular Shells/Augments/Plug | |
| Trident Hemispherical Shells (multiple | |
| configurations) | K013676, K143085 |
| Tritanium Shells (multiple styles) | K081171, K143085 |
| Restoration Anatomic Acetabular Shell | K142462, K151264 |
| Tritanium Multi-Hole Shell | K010170, K143085 |
| Trident AD Acetabular Shell (multiple styles) | K983502 |
| Trident HA PSL Shell (multiple styles) | K983382, K143085 |
| Trident T Shell | K040412 |
| Restoration ADM Acetabular Shell | K072020 |
| Restoration Acetabular Augments | K102019 |
| Acetabular Dome Hole Plug | K920868 |
| K942809 | |
| Acetabular Liners | |
| MDM Liners | K103233 |
| ADM/MDM X3 inserts | K093644 |
| ADM/MDM Duration Inserts, OD 42mm-52mm | K072020 |
| Trident X3 Liners (multiple sizes) | K033716 |
| K061434 | |
| K062419 | |
| Trident Crossfire Liners (multiple sizes) | K983502 |
| K991952 | |
| K021911 | |
| K020497 | |
| Trident Constrained Liner | K061654 |
| Trident All Polyethylene Constrained Liner | |
| Trident 10 degree Constrained Liner | P960047 |
| Trident Liners N2/Vac(multiple sizes) | K983502 |
| Femoral heads and Adapter Sleeves | |
| BIOLOX Delta Heads (Various sizes, styles) | K052718 |
| K070885 | |
| K041940 | |
| K051588 | |
| Co Cr Heads (various styles/sizes) | K993601 |
| K010757, K022077, K061434 | |
| K900836, K993601, K021310 | |
| K910988, K061434 | |
| K121308 | |
| Alumina C-Taper and V40 Heads (various sizes) | K023901, K971409 |
| K003391, K991952 | |
| Unitrax Endo Head (38, 40-56, 58, 61) | K902365, K014226 |
| Unitrax V40 Adapter Sleeve | K954077, K992570 |
| Unitrax C-Taper Adapter Sleeve | K121308 |
| Adapter Sleeves (various styles) | K003379 |
| K051737 | |
| K070885 | |
| Bone Screws and Distal Spacer | |
| Torx Screws | K894124 |
| GAP Plate Screws | K943549 |
| Osteolock Bone Screws | K903362 |
| Universal Distal Spacer | K914406 |
32
33
Device Description:
All of the subject devices have been found substantially equivalent in previous premarket indications. The purpose of this submission is to modify the labeling to add MR compatibility to the labeling for the devices indicated above, and to remove a contraindication for selected devices. There have been no changes made to the devices requiring 510(k) clearance - only the labeling is being modified.
Intended Use:
In general, these devices are intended for use in primary or revision hip arthroplasty. Specific indications appear below:
Trident PSL Shell, Trident Tritanium Shell, Trident Hemispherical Shell
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid o arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less ● likely to achieve satisfactory results.
- . Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Trident shells are intended for cementless fixation within the prepared acetabulum.
Tritanium Acetabular Shell System
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Tritanium Acetabular Shell System is intended for cementless use only.
Accolade II Femoral Stem, Secur-Fit Advanced Femoral Stem, Anato Femoral Stem
The indications for use for total hip arthroplasty with stems include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; ●
- rheumatoid arthritis;
- correction of functional deformity; ●
- revision procedures where other treatments or devices have failed; and, ●
34
-
nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head ● involvement that are unmanageable using other techniques.
Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners: -
. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade II, Secur-Fit Advanced and Anato Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty.
Exeter® V40TM Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Hip System is intended for use in total hip replacement. It is intended for cemented use only.
The Exeter® Hip is indicated for:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- o rheumatoid arthritis:
- o correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head ● involvement that are unmanageable using other techniques.
Restoration Anatomic Shell
Indications for Use
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, posttraumatic arthritis or late stage avascular necrosis.
- . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- o Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head ● involvement that are unmanageable using other techniques.
- Dislocation risks ●
When used with Constrained Liner:
35
- The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.
Omnifit HFX Femoral Stems
Indications:
For use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head. ●
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or ● distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum.
- . Salvage of failed total hip arthroplasty.
- Femoral neck fractures. ●
For use as a Total Hip Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, . post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.
Omnifit EON Cemented Femoral Stems
Indications
For use as a Bipolar Hip Replacement:
- . Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- o Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty. ●
For use as a Total Hip Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, . post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less . likely to achieve satisfactory results.
36
Secur-Fit Max and Secur-Fit Max Plus Hip Stems
Secur-Fit Max and Secur-Fit Max Plus Hip stems are single use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
Indications for use as a Total Hip Replacement include:
- noninflammatory degenerative joint disease. including osteoarthritis and avascular necrosis:
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Accolade C Femoral Stems
The Accolade C Femoral Stems are single-use devices intended for cemented fixation.
Indications for use as a Total Hip Replacement include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; ●
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, ●
- o treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Accolade HFx Femoral Stems
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; ●
- o rheumatoid arthritis:
- correction of functional deformity; ●
- revision procedures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head ● involvement that are unmanageable using other techniques.
Accolade TMZF and Accolade TMZF Plus Femoral Stems
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including ● osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
37
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head ● involvement that are unmanageable using other techniques.
- . Revision procedures where other treatments or devices have failed.
Restoration Acetabular Wedge Augments
The indications for use of the Restoration Acetabular Wedge Augments:
General Indications for Total Hip Replacement Components:
- o Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications Specific to the Acetabular Wedges:
- . As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.
Acetabular Augments are intended for cementless use only to the bone interface, and are affixed to the mating cup using bone cement
Trident AD Acetabular shells
The Trident AD Acetabular shells are single use devices. The shell is intended for cemented or cementless fixation within the prepared acetabulum. The Trident AD Acetabular Component System is compatible with any appropriately selected Howmedica Osteonics hip stem/femoral head combination.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ●
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated ● by deficiencies of the acetabulum.
Trident T Acetabular shells
The Trident Acetabular shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.
38
General Indications for Total Hip Replacement Components:
- . Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less ● likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated ● by deficiencies of the acetabulum.
Restoration ADM System, Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert
The indications for use of the total hip arthroplasty prostheses include:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head ● involvement that are unmanageable using other techniques.
- Dislocation risks.
These devices are intended for cementless use only
Acetabular Dome Hole Plug
The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the acetabular cup. The Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell.
Indications
- · In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.
Trident X3, Trident Crossfire, Trident X2Vac and Trident X3/Crossfire Elevated Rim Acetabular Liners
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, ● post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less . likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated ● bv deficiencies of the acetabulum.
Trident® Constrained Acetabular Insert
The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
39
BIOLOX Delta Ceramic Heads (C-Taper, Universal Taper, V40 to Universal Taper Adapter Sleeve, and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less ● likely to achieve satisfactory results.
- . Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
For Use as a Bipolar Hip Replacement
- . Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or ● distortion.
- Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty ●
V40 BIOLOX Delta Ceramic Heads
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedures
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less ● likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. .
- Aseptic necrosis of the femoral head.
- Osteo-. rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other considerations:
- Pathological considerations or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
- . Salvage of failed total hip arthroplasty
Alumina C-Taper Ceramic Heads
40
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, ● post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or ● distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty .
Alumina V40 Ceramic Heads
- Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative arthritis ● (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
- Rheumatoid arthritis ●
- Correction of functional deformity ●
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated ● by the deficiencies of the acetabulum;
- . Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques;
- Revision procedures where other treatments or devices have failed.
C-Taper CoCr Femoral Heads (LFIT and non-LFIT)
For use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions 1.
-
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement 3. or distortion.
Other Considerations:
-
- Pathological conditions or age considerations which indicate a more conservative approach to the acetabulum and the avoidance of the use of bone cement in the acetabulum.
-
- Salvage of failed total hip arthroplasty.
Indications for use as part of a Total Hip Replacement include:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid 1. arthritis, post-traumatic arthritis or late stage avascular necrosis.
-
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
41
-
- Clinical management situations where arthrodesis or alternate reconstructive techniques are less likely to achieve satisfactory results.
V40 CoCr Femoral Heads (LFIT and non-LFIT)
- Clinical management situations where arthrodesis or alternate reconstructive techniques are less likely to achieve satisfactory results.
-
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; ●
-
Rheumatoid arthritis
-
Correction of functional deformity
-
Revision procedures where other treatments or devices have failed
-
Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Unitrax Endoprosthesis, Unitrax V40 Adapter Sleeve, Unitrax C-Taper Adapter Sleeve
- The Howmedica Osteonics Unitrax Endoprosthesis, and the Unitrax V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and non-unions. The Unitrax C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or non-unions, aseptic necrosis of the femoral head/neck and osteo- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis.
Universal Distal Spacer
Howmedica Osteonics Corp.'s accessory products for cemented arthroplasty are optional devices intended to assist in the preparation, implantation and/or positioning of a femoral implant intended for cemented application.
Indications
For cement spacers, mid-shaft restrictors and Cement Plugs:
- In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be . advantageous.
Torx Screws, GAP Plate Screws and Osteolock Bone Screws
- o Howmedica Osteonics Torx Cancellous Bone Screws are intended for supplemental fixation of associated Howmedica Osteonics cementless Acetabular Shells or Howmedica Osteonics Tibial Tray components.
- Howmedica Osteonics Osteolock Bone Screws are intended for supplemental fixation of associated ● cementless Trident Tritanium Multihole Acetabular shells, Restoration Acetabular Augments, and Restoration Anatomic Shell.
- Howmedica Osteonics Restoration GAP Plate Screws are intended only for fixation of the dome and ● iliac plates of the associated Howmedica Osteonics Restoration GAP Acetabular Shells, Trident Tritanium Hemispherical Multihole Acetabular Shells, Restoration Acetabular Augments and Restoration Anatomic Shell.
V40 to C-Taper Adapter Sleeve For Use as a Total Hip Replacement
42
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less o likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular ● involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative 0 acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
Summary of Technological Characteristics:
There have been no changes requiring 510(k) clearance to the technological characteristics of the Stryker Total Hip systems as a result of the revision to the labeling. The subject devices have the same design and are manufactured from the same materials as the predicate devices.
Non-Clinical Testing:
The following non-clinical laboratory testing was performed to determine substantial equivalence:
Non-clinical testing as outlined in the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and FDA Staff", dated December 11, 2014 was conducted to characterize the compatibility of Stryker Orthopaedics total hip passive implants in the MR environment. FDA draft guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance for Industry and FDA Staff", dated June 29, 2015 was also consulted for the heating evaluations performed. Testing was performed according to the standards listed below:
- Magnetically Induced Displacement Force performed per ASTM F2052-06 and ASTM ● F2052-14, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment
- 0 Magnetically Induced Torque - performed per ASTM F2213-06 (Reapproved 2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment
- Image Artifact performed per ASTM F2119-07 (Reapproved 2013), Standard Test ● Method for Evaluation of MR Image Artifacts from Passive Implants
43
- Heating by RF Fields per ASTM F2182-11a, Standard Test Method for Measurement of 0 Radio Frequency Induced Heating near Passive Implants during MR Imaging
The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned. Additionally, for certain devices, a contraindication was removed.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The Stryker Orthopaedics Hip System devices are substantially equivalent to the predicate devices identified in this premarket notification.
Device comparisons showed that the subject devices have the same intended use, and substantially equivalent design, materials and operational principles to the predicate devices.