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.

Device Description

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.

AI/ML Overview

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.

Summary

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K082567

OCT 3 - 2008

Summary of Safety and Effectiveness Stryker® Compartmental Knee System Line Extension

Proprietary Name:	Stryker® Compartmental Knee System Line Extension
Common Name:	Knee Prosthesis
Classification Name and Reference:	Knee joint femortotibial polymer/metal semi constrained cemented prosthesis. 21 CFR §888.3530
	Knee joint patellofemoral polymer/metal semi constrained cemented prosthesis. 21 CFR §888.3540
	Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. 21 CFR §888.3520
	Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. 21 CFR §888.3530
Device Product Code:	87 NPJ, 87 KRR, 87 HSX, 87 HRY
For Information Contact:	Francisco Haro, Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5493 Fax: (201) 831-6038
Date Summary Prepared:	September 3, 2008

Description:

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Intended Use:

Indications for Use:

. 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.

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Substantial Equivalence:

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a wing-like structure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

OCT 3 - 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Francisco Haro Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K082567

Trade/Device Name: Stryker® Compartmental Knee System Line Extension Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: IIRY, NPJ, HSX, KRR Dated: September 3, 2008 Received: September 4, 2008

Dear Mr. Francisco Haro:

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 l'ood, 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 gencral 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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 Part 801); good manufacturing practice requirements as set 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mikkelson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082567 510(k) Number (if known):

Device Name: Stryker® Compartmental Knec System Line Extension

Indications for Use;

The Stryker® Compartmental Knee System line extension is intended for use 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 Knec System line extension 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 knee 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 condyle/tibial plateau.

These components are single use only and are intended for implantation with 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)

Mark Mill

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,

(Division Sign-Off)
Division of Anesthesiology, General Hospital

Division of General, Restorative, and Neurological Devices

Infection Control, Dental Devices
510(k) Number:

510(k) Number

Regulation Number and Section

§ 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.