UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS

K050373 · Arthrosurface, Inc. · HSX · Oct 11, 2005 · Orthopedic

Device Facts

• Record ID: K050373
• Device Name: UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
• Applicant: Arthrosurface, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Oct 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) is indicated for use as a partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.

Device Story

UniCAP™ is a unicompartmental knee resurfacing system designed for partial knee replacement. The system consists of a low-profile femoral articular component (Cobalt-Chromium-Molybdenum alloy) that mates to a threaded Ti-6Al-4V ELI taper post via a taper interlock, and an all-polyethylene (UHMWPE) tibial resurfacing component. The device is implanted by a surgeon in an OR setting. It functions by resurfacing the affected knee compartment while preserving existing compartmental structures and soft tissues. The femoral component features a spray-applied CP Titanium coating on the bone-contact surface to facilitate fixation with bone cement. The tibial component is available in multiple thicknesses to accommodate varying patient anatomy. By requiring minimal bone and soft tissue resection, the device provides a precise fit, aiming to restore joint articulation and alleviate pain associated with degenerative disease or trauma.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Femoral component: Cobalt-Chromium-Molybdenum alloy (ASTM F799, ASTM F1537) with CP Titanium coating. Taper post: Ti-6Al-4V ELI alloy (ASTM F136). Tibial component: UHMWPE (ASTM D 648). System is a non-constrained, cemented, metal/polymer knee prosthesis. Components are modular with a taper interlock. Tibial thicknesses range from 6.0 mm to 7.5 mm.

Indications for Use

Indicated for patients requiring partial knee replacement due to compartmental primary or post-traumatic degenerative disease, previous tibial condyle/plateau fractures, deformity, or revision of previous arthroplasty. Intended for use with bone cement.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Miller/Galante Precoat Unicompartmental Knee System (K880155)
• Link® Endo-Model™ Sled Uni-Knee System (K954186)
• EUIS® Unicompartmental Knee System (K033769)
• Stelkast Unicondylar Knee System (K032824)

Submission Summary (Full Text)

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## 510(K) Summary of Safety and Effectiveness (21 CFR 807.92) [21 CFR 807.87(h)]

### Unicompartmental Knee Resurfacing Prosthesis (UniCAP™)

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.87(h), this information serves as a Summary of Safety and Effectiveness for the Unicompartmental Knee Resurfacing Prosthesis (UniCAP™).

| Submitted By: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 3, 2005 |
| Contact Person: | Steven W. Ek, Chief Operations Officer |
| Proprietary Name: | Unicompartmental Knee Resurfacing Prosthesis<br>(UniCAP™) |
| Common Name: | Knee joint femorotibial metal/polymer non-<br>constrained cemented prosthesis |
| Device Classification: | Class II |
| Review Panel: | Orthopedic |
| C.F.R. identification<br>reference: | 21 CFR § 888.3520 (2004) |
| Product Code: | HSX |
| Indications for Use: | Partial replacement of the articulating surfaces of<br>the knee when only one side of the joint is affected<br>due to the compartmental primary degenerative or<br>post-traumatic degenerative disease, previous<br>tibial condyle or plateau fractures, deformity or<br>revision of previous arthroplasty. This device is<br>intended to be used with bone cement. |

K050373

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### Substantial Equivalence Information:

The Arthrosurface Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) has been compared with the following legally marketed devices to which the sponsor claims substantial equivalence:

- Miller/Galante Precoat Unicompartmental Knee System (Zimmer, Inc.) 제 (K880155)
- Link® Endo-Model™ Sled Uni-Knee System, (Link America, Inc). . (K954186)
- EUIS® Unicompartmental Knee System (Howmedica Osteonics) l (K033769)
- Stelkast Unicondylar Knee System (Stelkast Co.) (K032824)

### Device Description Summary

The Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) incorporates a low-profile femoral articular component that mates to a taper post via a taper interlock. The femoral resurfacing component articulates against an allpolyethylene tibial resurfacing component. The UniCAP™ implants allow resurfacing of the compartment utilizing the undisturbed compartmental structures and soft-tissues.

The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The femoral articular component has a bone contact surface that is coated with a spray-applied CP Titanium coating (identical to sponsor's previously approved devices) and a xpolished articular bearing surface.

The taper post component is a cylindrical threaded stem 20mm in length, manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The post has a tapering major and minor diameter, a full-length cannulation, and a proximal female taper bore.

The tibial resurfacing component is comprised of ultra high molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM D 648. The tibial component is offered in a range of thickness ( 6.0 mm, 6.5 mm, 7.0 mm and 7.5 mm) accommodate a variety of tibial surface conditions.

The components have been designed to allow a minimum amount of bone and soft tissue resection. The UniCAP™ system offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular components to the existing anatomy.

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0CT 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William Ciavarra Director, Quality Assurance & Regulatory Affairs Arthrosurface, Inc. 28 Forge Parkway Franklin, Massachusetts 02038

Re: K050373

Trade/Device Name: Unicompartmental Knce Resurfacing Prosthesis (UniCAPTM) Regulation Number: 21 CFR 888.3520 Regulation Name: Knec joint femorotibial metal/polymer non constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: September 21, 2005 Received: September 22, 2005

Dear Mr. Ciavarra:

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 rcclassified 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). You may, therefore, market the device, subject to the general 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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

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#### Page 2 -- Mr. William Ciavarra

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rooduct 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) This leket will and in your he FDA finding of substantial equivalence of your device to a legally premated 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 Office of Compliance at [phone]. 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 Ectoral International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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): 长 050 3 9 3

Device Name: Unicompartmental Knee Resurfacing Prosthesis (C.A.P.)™

Indications for Use:

The Unicompartmental Knee Resurfacing Prosthesis (UniCAP ™) is indicated for use as a partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.

Prescription Usc (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Division of General, Restorative, and Neurological Devices | |

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Posted November 13, 2003

| 510(k) Number | K050373 |
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