(71 days)
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or The only ar 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 companents 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 an 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.
The Stryker® Compartmental Knee System consists of sterile, single-use components intended for r ne our new - Companiside of the patellofemoral joint and/or the condyle region(s) of the femoral rophoominent of the system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Osteonics' 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.
This 510(k) summary describes a new medical device, the Stryker® Compartmental Knee System, and demonstrates its substantial equivalence to previously marketed devices. However, it does not contain information regarding pre-established acceptance criteria for device performance or a study demonstrating the device meets such criteria.
The document focuses on:
- Device Identification and Description: Detailing the components and intended use of the Stryker® Compartmental Knee System (sterile, single-use components for knee arthroplasty).
- Indications for Use: Listing the specific conditions for which the device is intended (e.g., degenerative arthritis, failed previous surgeries).
- Substantial Equivalence: Asserting that the device is substantially equivalent to existing predicate devices based on indications for use, materials, and operational principles. The document explicitly states: "The analyses armonstrate that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement."
- FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) premarket notification and found the device substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving the device meets those criteria because this information is not present in the provided text.
The document is a regulatory submission for premarket clearance based on substantial equivalence to existing devices, not a performance study against specific acceptance criteria. This type of submission relies on the safety and effectiveness of the predicate devices.
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DEC 2 7 2005
510(k) Summary of Safety and Effectiveness Stryker® Compartmental Knee System
Submission Information
| Name and Address of the Sponsorof the 510(k) Submission: | Howmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430 |
|---|---|
| For Information contact: | Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581 Fax: (201) 831-603 |
| Date Summary Prepared: | December 9, 2005 |
| Device IdentificationProprietary Name:Common Name:Proposed Regulatory Class: | Stryker® Compartmental Knee SystemKnee Prosthesis ComponentsClass II |
Classification Name, Reference and Product Code:
Classificanon Name, Netal, Semi-constrained, Cemented Prosthesis, 21 CFR §888.3530, 87 NPJ Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis, 21 CFR 888.3540, 87 KRR Riles John Patononomal por J. Mon-Constrained, Cemented, Metal Polymer, 21 CFR 888.3520, 87 HSX I Tosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, 21 CFR §888.3530, 87 HRY
Description:
The Stryker® Compartmental Knee System consists of sterile, single-use components intended for r ne our new - Companiside of the patellofemoral joint and/or the condyle region(s) of the femoral rophoominent of the system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Osteonics' 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.
Indications for Use
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or The only ar 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 companents 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 an unicompartmental knee prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or .
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- 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.
Substantial Equivalence:
Substantial Equivalent to its predicates for patellofemoral arthroplasty and femorotibial The device is substantially equivalent to this promaterials, and operational principles. The analyses armonstrate that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
K052917 Re:
Trade/Device Name: Stryker Compartmental Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: NPJ, KRR, HSX, HRY Dated: December 13, 2005 Received: December 13, 2005
Dear Ms. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocation of 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 commerce provided 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). and Cosmetic Free (110) keep the device, subject to the general controls provisions of the Act. The r ou may , the so received 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.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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
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Page 2 - Ms. Vivian Kelly
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quart) Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxilation control po begin marketing your device as described in your Section 510(k) I ms letter will and w you to ough finding of substantial equivalence of your device to a legally prematication. The PDF intentig sification 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 If you desire specific darioliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
to
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Stryker® Compartmental Knee System
Indications for Use:
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral The Our your which - Compariminents where conditions exist that cannot be addressed by a and of annoonal the femorotibial or patellofemoral regions of the knee. The indications for single device to treat and remorederer of 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 knee prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or .
- r is an atternation 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 | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K052917 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.