(29 days)
The Stryker® Compartmental Knee System Line Extension consists of sterile, single-usc devices intended for replacement of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The Stryker® Compartmental Knee System Line Extension includes Triathlon® PKR femoral condyle regions for cither the right or left knee.
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:
- . Degenerative arthritis in the distal femur and patella.
- Patients with a history of patellar dislocation or patella fracture, .
- . Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knec prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, . or
- Where bone stock is of poor quality or inadequate for other reconstructive techniques . as indicated by deficiencies of the femoral condvle/tibial plateau.
These components are single use only and are intended for implantation with bone cement only.
The Stryker® Compartmental Knee System consists of sterile, single-use components intended for replacement of the femoral side of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Ostconics' knee systems for patellofemoral and unicondylar arthroplasty. The system allows the physician to choose the most appropriate option to treat the patient with patellofemoral arthroplasty and/or unicondylar arthroplasty as needed.
The provided document, K082567, is a 510(k) premarket notification for the Stryker® Compartmental Knee System Line Extension. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to prove device performance against specific acceptance criteria. Therefore, the document does not contain information related to acceptance criteria or studies providing device performance metrics in the way one might expect for a new, novel device seeking de novo clearance or requiring a PMA.
Instead, the "study" described is an "analysis" demonstrating substantial equivalence, which primarily focuses on comparing the new device to existing predicate devices based on design, materials, and intended use.
Here's an breakdown of the requested information based on the provided text, and where the requested information is not applicable or not present in a 510(k) submission of this nature:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantitative performance acceptance criteria from a new clinical study. | Not Applicable. No new quantitative device performance metrics are reported against predefined acceptance criteria for the new device as part of this submission. The "performance" is inferred from the established safety and effectiveness of the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not Applicable. There was no "test set" in the context of a new clinical study for this 510(k) submission.
- Data Provenance: Not Applicable. This submission primarily relies on a comparison to existing predicate devices and their known performance, rather than new data generated from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Applicable. No new ground truth was established by experts for a test set as part of this 510(k) submission. Substantial equivalence relies on the established safety and effectiveness of predicate devices, which would have undergone their own regulatory evaluations.
- Qualifications of Experts: Not Applicable.
4. Adjudication method for the test set
- Adjudication Method: Not Applicable. There was no test set or adjudication process described as part of this 510(k) submission.
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
- MRMC Comparative Effectiveness Study: No. This is a knee prosthesis, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is entirely irrelevant to this device.
- Effect Size: Not Applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is a physical knee prosthesis, not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for a 510(k) submission for a device like this is the established safety and efficacy of the legally marketed predicate devices. The new device is deemed "substantially equivalent" if it shares similar technological characteristics and intended use, and raises no new questions of safety or effectiveness compared to the predicates.
8. The sample size for the training set
- Sample Size for Training Set: Not Applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not Applicable.
Summary of the "Study" for Substantial Equivalence:
The "study" or evidence provided is an analysis of substantial equivalence. The document states:
"The device is substantially equivalent to its predicates for patellofemoral arthroplasty and femorotibial arthroplasty in regards to intended use, design, materials, and operational principles. The analysis demonstrated that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement."
This means Stryker compared the new "Compartmental Knee System Line Extension" to previously cleared predicate devices, demonstrating that its features (design, materials, intended use, and how it works) are similar enough to those predicates that it doesn't raise any new safety or effectiveness concerns. The FDA agreed with this assessment, issuing the 510(k) clearance based on this demonstration of substantial equivalence.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee 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 includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.