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 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.

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 1.
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:

1. 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.
1. 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.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
1. 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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for a labeling update of Stryker Orthopaedics Total Hip Systems, not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a labeling update to include MR compatibility and remove a contraindication. It mentions non-clinical testing for MR compatibility but does not provide specific acceptance criteria or performance numbers in the requested format.

Here's a breakdown of what can be extracted and what is not available:

Acceptance Criteria and Study Supporting Device Performance

Not directly available. This document is a 510(k) summary for a labeling update, not an original submission demonstrating device performance against specific clinical or non-clinical acceptance criteria with quantitative results. It describes non-clinical testing performed to update MR compatibility labeling, but it does not present acceptance criteria in a table format with corresponding device performance metrics.

What is present regarding testing:
Non-clinical laboratory testing was performed to characterize the MR compatibility of the devices. The tests were conducted according to specific ASTM standards:

ASTM F2052-06 and ASTM F2052-14 for Magnetically Induced Displacement Force.
ASTM F2213-06 (Reapproved 2011) for Magnetically Induced Torque.
ASTM F2119-07 (Reapproved 2013) for Image Artifact.
ASTM F2182-11a for Heating by RF Fields.

The document states that the labeling was modified to include the MR conditional symbol and provide parameters for safe scanning, and for certain devices, a contraindication was removed. This implies that the devices met the requirements of these ASTM standards for MR compatibility, allowing for the labeling update. However, no specific numerical "acceptance criteria" or "reported device performance" are provided in a table.

Detailed Breakdown of Requested Information:

A table of acceptance criteria and the reported device performance
- Not available in this document. The document describes the type of non-clinical tests performed (e.g., Magnetically Induced Displacement Force per ASTM F2052-06) for MR compatibility, but it does not provide a table with specific numerical acceptance criteria (e.g., "Displacement less than X") and the corresponding measured performance (e.g., "Measured displacement Y"). It only states that the labeling was updated to reflect MR compatibility based on these tests.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document mentions non-clinical laboratory testing but does not specify sample sizes for these tests (e.g., how many hip components were tested for MR compatibility). It is a regulatory submission, not a research paper detailing experimental methodology. Data provenance for non-clinical lab tests is not typically documented in this way in a 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not available. The testing described is non-clinical "MR compatibility" testing performed in a laboratory setting, not clinical evaluation requiring expert interpretation or ground truth establishment in a diagnostic context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not available. As the testing is non-clinical (laboratory-based MR compatibility), there is no adjudication process involving human interpretation of results in the way it would be for a clinical diagnostic study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This submission is for a labeling update for existing orthopedic implants and does not involve AI or any diagnostic imaging interpretation requiring an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a labeling update for existing orthopedic implants and does not involve an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not available. For the non-clinical MR compatibility testing, the "ground truth" would be the physical properties and responses of the hip system components under MR conditions, as measured by the ASTM standards, not a clinical "ground truth" like pathology or expert consensus. These are engineering measurements.
The sample size for the training set
- Not applicable. This submission relates to physical orthopedic implants and MR compatibility testing, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established
- Not applicable. This submission relates to physical orthopedic implants and MR compatibility testing, not a machine learning algorithm that requires a training set.

In summary, the provided document is a regulatory submission focusing on demonstrating substantial equivalence for a labeling change for established orthopedic implants, particularly concerning MR compatibility. It outlines the types of non-clinical tests performed but does not present a detailed study report with specific acceptance criteria, performance metrics, or clinical study details as requested.

Summary

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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

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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

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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)

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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)

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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)

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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
1. Aseptic necrosis of the femoral head.
1. 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.
1. 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.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
1. 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 Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Margaret KlippelSenior Regulatory Affairs Project ManagerHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Telephone: 201-831-5559Fax: 201-831-4559
Alternate Contact	Patricia Setti-LaPerchManager, Regulatory AffairsHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Telephone: 201-831-5938Fax: 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-constrainedporous-coated uncemented prosthesis 21 CFR §888.3358
	Hip joint metal/polymer constrained cementedor uncemented prosthesis 21 CFR §888.3310
	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis 21 CFR §888.3353
	Hip joint metal/polymer semi-constrained cemented prosthesis 21CFR §888.3350
	Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis 21 CFR §888.3360
	Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented 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, porousuncementedKWZ - prosthesis, hip, constrained, cemented or uncemented,metal/polymerLZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer,cemented or non-porous, uncementedMEH - prosthesis, hip, semi-constrained, uncemented,metal/polymer, non-porousJDI - prosthesis, hip, semi-constrained, metal/polymer, cementedLWJ - prosthesis, hip, semi-constrained, metal/polymer,
	uncementedKWL - prosthesis, hip, hemi-, femoral, metalKWY - prosthesis, hip, hemi-, femoral, metal/polymer, cementedor uncementedMAY - prosthesis, hip, semi-constrained, metal/ceramic/polymer,cemented or non-porous cemented, osteophilic finishMBL-prosthesis, hip, semi-constrained, uncemented,metal/polymer, porousHWC - 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 (multipleconfigurations)	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

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Device Description:

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, ●

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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:

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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.

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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

Indications:

Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including ● osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.

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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

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

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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

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

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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

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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.
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:

1. 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.
1. 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.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.

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1. 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

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

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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

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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.

Regulation Number and Section

§ 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.