FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
1. Rheumatoid arthritis:
1. 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.
Dislocation risks
MDM Liners are intended for cementless use only.

Universal Cement Restrictor, OmniFit Distal Cement Spacer
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.

Artisan Bone Plug
These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.

Trident® II Acetabular System (Trident II Cups (Clusterhold HA, Tritanium Clusterhole, Tritanium Multihole, Tritanium Solidback), 6.5mm Low Profile Hex Screw, Hex Dome Hole Plug
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic 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 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 Trident® II Acetabular Shells are indicated for cementless use only.

Restoration® Modular Hip System
The Restoration® Modular Hip System is indicated for use in:
· Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

Rheumatoid arthritis
· Correction of functional deformity;
Revisions procedure 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 indications specific to the Restoration Modular Hip System
The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Accolade II Femoral Stems, Anato Femoral Stem, Secur-Fit Advanced
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.
The Stems are intended for cementless use only and are intended for total and hemiarthroplasty.

TRIDENT AND TRITANIUM® ACETABULAR COMPONENTS
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic 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 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 HOWMEDICA OSTEONICS TRIDENT and TRITANIUM Acetabular Shells are intended for cementless use only. Dome hole plug is indicated for cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous

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 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.

DALL-MILES® SYSTEMS
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hig; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the greater trochanter due to extended trochanteric osteotomies.

Exeter® V40™ Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Femoral Hip System 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.
The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.

Exeter Centralizer, EXETER Intramedullary Plug

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

1. rheumatoid arthritis;
1. correction of functional deformity;
1. 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.
The Exeter Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Exeter Centralizer is intended to be used with bone cement.
The Exeter Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:

Painful, disabling joint disease of the hip 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 techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.

Restoration GAP II Acetabular Shell
Painful, disabling joint disease of the hip resultive 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 techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.

Gap Screws, Torx Screws, and Osteolock Bone Screws
HOWMEDICA OSTEONICS Torx Cancellous Bone Screws are intended for supplemental fixation of associated HOWMEDICA OSTEONICS cementless Acetabular Shells.
· HOWMEDICA OSTEONICS RESTORATION GAP Plate Screws are intended for fixation of the dome and illac plates of the associated HOWMEDICA OSTEONICS RESTORATION GAP Acetabular Shell, TRIDENT TRITANIUM Hemispherical Multihole Acetabular Shells, restoration Acetabular Augments, and Restoration Anatomic shells.

Insignia Hip Stem
Hip Arthroplasty Indications:
• Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
· Correction of functional deformity
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Insignia Hip Stems 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.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components: • When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks
Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Omnifit HFX Femoral Stems
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, rheumatic 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 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
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, 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 techniques are less likely to achieve satisfactory results.
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.

Restoration Anatomic Shell
• Painful, disabling joint disease of the hip 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 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.

Trident Constrained Acetabular Insert/ Constrained Acetabular Insert
The 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.

Trident X3, Trident Crossfire, and Trident X3/Crossfire Elevated Rim Acetabular Liners
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic 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 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.

UHR Bipolar

· 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.

Unitrax V40 Head, V40 Adapter Sleeve and C-Taper Adapter Sleeve
The HOWMEDICA OSTEONICS Unitrax Endoprosthesis, and the V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and nonunions. The C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or nonunions, aseptic necrosis of the femoral head/neck and oster- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the ad of the endoprosthesis.

BIOLOX Delta Ceramic Heads (V40, C-Taper and Universal and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended 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, rheumatic arthritis or late stage avascular necrosis.

· Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative 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.
The general intended use for these devices is "In general, these devices are intended for use in primary or revision hip arthroplasty."

Alumina C-Taper and V40 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 avascular necrosis.
· Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative 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.
Additional indications for the Alumina C-Taper Ceramic Heads
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

Co Cr Femoral Heads (C-Taper and V40 Taper, LFIT and non-LFIT)
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative 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.

Accolade C Femoral Stems, Accolade HFx Femoral Stems
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 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 V40TM 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.

Device Description

The devices covered by this submission are Stryker Total Hip components which include femoral stems, acetabular shells, liners, femoral heads, acetabular augments, acetabular bone screws, acetabular plugs, cables, trochanteric grips, cement restrictors, and distal femoral spacers. All devices are commercially available and have been cleared in prior 510(k) submissions.

All the subject devices have been cleared for MR conditional in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a labeling update for Stryker Orthopaedics Hip Systems. It explicitly states that no changes have been made to the devices themselves, only to the MR conditional information in the instructions for use.

Therefore, the usual format for acceptance criteria and studies proving the device meets those criteria (which would typically involve performance metrics for an AI/software-based device) is not applicable here. This submission is about demonstrating that the updated MR Conditional labeling information is safe, not about a new or modified device's performance against clinical endpoints.

However, I can extract information related to the testing performed to support the updated labeling, which serves as the "study" in this context.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria (for MR Conditional Labeling Safety) and Reported Device Performance:

Acceptance Criteria Category (for MR Conditional Labeling Safety)	Reported Device Performance (as described in the document)
Safety in Magnetic Resonance (MR) Environment	New testing performed to comprehensively assess the RF-related heating effects induced by the subject devices when implanted into bone.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in terms of number of devices or scenarios tested, but the document mentions that testing was "comprehensively" performed.
Data Provenance: The testing was conducted by the manufacturer, Stryker Orthopaedics, to obtain data for updating the MR conditional information in the labeling. This is non-clinical testing.
Retrospective or Prospective: This would be considered prospective testing, as new tests were conducted specifically to gather data for the labeling update.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This concept is not applicable here. The "ground truth" for MR Conditional labeling is established through physical testing and engineering analysis according to regulatory standards and guidance documents, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable. As the testing is non-clinical (device safety in an MR environment), there's no "adjudication" in the sense of clinician agreement on an outcome. The results are based on direct measurements from physical tests.

5. 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:

No. This type of study is for evaluating the clinical effectiveness of AI/software in assisting human readers (e.g., radiologists, pathologists). This submission is for a labeling update of a physical medical device (hip implants) regarding its MR compatibility and does not involve AI or human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This is not an AI/algorithm-based device. It is a physical orthopedic implant.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on non-clinical testing results that demonstrate the safety of the device in an MR environment, specifically regarding RF-related heating effects. This is a combination of physical measurements and engineering analysis in accordance with FDA guidance documents. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. This product is a physical device, not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

In Summary:

This FDA 510(k) notification is for a labeling change related to MR compatibility of a hip implant system, not for a new or modified device's clinical performance or an AI/software device. The "study" referenced is non-clinical testing to ensure the safety parameters provided in the updated labeling are accurate and supported by data, specifically related to RF-induced heating. The acceptance criteria and "performance" are therefore framed around meeting the requirements of the FDA guidance document for MR safety testing.

Summary

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.