Search Results

The Stryker Orthopaedic Acetabular Shells for use with the Total Hip Instruments are intended for use in total hip arthroplasty and are intended for either primary or revision total hip arthroplasty. The Stryker Orthopaedic Hip Implant Stems for use with the Total Hip Instruments are intended for use in total or hemi-arthroplasty of the hip and are intended for either primary or revision procedures. The Direct Superior Approach does not change the intended use of the subject devices.

Indications for Use (Trident PSL Shell, Tritanium Shell, Trident Hemispherical Shells):

• 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.

Indications for Use (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.

Indications for Use (Accolade II 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 Accolade II Femoral 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.
  Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Secur-Fit Advanced Hip 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 Secur-Fit Advanced 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.
  Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Anato Hip 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 Anato Hip 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 Anato Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.

The devices covered by this submission include Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments. The Instruments consist of Retractors, Cup Impactors, U-Joint Bolt Driver, Alignment Guide, Angled Reamer Handle, Instrument Trays and a Case. All instruments are hand-held surgical instruments used during orthopaedic surgery and are nonsterile, reusable devices. All Class II devices in this submission have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The acetabular shells and femoral stems are manufactured from the following materials: titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium plasma spray, commercially pure titanium and PureFix® hydroxylapatite (HA).

This document is a 510(k) premarket notification from Stryker Orthopaedics to the FDA for their Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach.

It is important to note that this submission is for a labeling modification to introduce a new surgical approach (Direct Superior Approach) for existing devices, not for a new device requiring extensive performance studies. Therefore, the details requested for acceptance criteria and studies proving device performance (like sample sizes, expert qualifications, etc., which are typically associated with evaluating a new device's diagnostic or predictive performance) are largely not applicable in the context of this specific regulatory submission.

Here's an attempt to address your request based on the provided document, highlighting what is (and isn't) present:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report on device performance based on a study, because the submission is for a labeling modification of already cleared and marketed devices. The core of the submission is to demonstrate that the new surgical approach (Direct Superior Approach) does not fundamentally change the intended use, safety, or effectiveness of the previously cleared devices.

Instead of performance metrics, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the new labeling (for the Direct Superior Approach) does not raise new questions of safety or effectiveness and that the devices, when used with this new approach, are as safe and effective as existing legally marketed predicate devices.

The "performance" in this context is the general safety and efficacy of the existing devices, which was established in their original 510(k) clearances.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No specific test set to evaluate device performance for a new device was used. The submission focuses on the surgical approach for existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment for a diagnostic or predictive device was involved. The safety and effectiveness of the devices themselves were established in prior 510(k)s.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring ground truth adjudication.

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

Not applicable. This is not an AI/diagnostic device submission.

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

Not applicable. This is not an AI/diagnostic device submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the sense of a new performance evaluation for a new device. The "ground truth" for this submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Not applicable. No new device or algorithm requiring a training set was involved.

9. How the ground truth for the training set was established

Not applicable. No new device or algorithm requiring a training set was involved.

Summary of the Study (as per the document):

The document explicitly states:

• Non-Clinical Testing: "Performance testing was not required in support of this submission because this submission covers a labeling modification to introduce an additional surgical protocol, Direct Superior Approach."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."

Conclusion of the Study:

The "study" in this case is the review of the modified labeling and comparison to predicate devices, rather than experimental testing of the device itself.

The conclusion is that the Stryker Orthopaedics Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach are substantially equivalent to the predicate devices identified in the premarket notification. This substantial equivalence is based on:

• The intended use and indications for the implants with the Direct Superior Approach being identical to those of the cleared predicate devices.
• The materials, design features, and functionality for the components being substantially equivalent to previously cleared predicate devices.
• The fundamental scientific technology of the modified device (i.e., the surgical instruments for the new approach) not having changed relative to the predicate devices.
• The material and design of the Total Hip Surgery Instruments for use with the Direct Superior approach being identical to those of the predicate devices cleared for use with other approaches (Posterolateral Approach and Direct Anterior Approach), and their operational principles being similar.

In essence, the "study" for this submission was a comparative analysis of design, materials, intended use, indications for use, and operational principles between the proposed devices (with the new approach) and their already cleared predicates, confirming that no new safety or effectiveness concerns were raised by adding the Direct Superior Approach to the labeling.

Ask a specific question about this device