UNICOMPARTMENTAL KNEE

K072704 · Valpo Orthopedic Technology, Inc. · HRY · Feb 19, 2008 · Orthopedic

Device Facts

• Record ID: K072704
• Device Name: UNICOMPARTMENTAL KNEE
• Applicant: Valpo Orthopedic Technology, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Feb 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. This device is intended for cemented use only.

Device Story

Unicompartmental knee prosthesis consisting of femoral and tibial components; designed for non-constrained medial compartment replacement. Femoral component: Cobalt Chrome Alloy, asymmetrical shape, post and keel for stability. Tibial component: Ultra-High Molecular Weight Polyethylene (UHMWPe), hemispherical articular surface, dovetailed undersurface for mechanical cement lock. Used in orthopedic surgery; implanted by surgeons. System includes cement delivery instruments, syringes, adapters, and trials for preoperative planning. Provides natural weight distribution and flexion; restores joint function in patients with single-compartment disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Cobalt Chrome Alloy (femoral), UHMWPe (tibial). Design: Non-constrained, semi-constrained cemented prosthesis. Features: Asymmetrical femoral component, dovetailed tibial undersurface for cement fixation. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring medial compartment knee replacement due to primary or post-traumatic degenerative disease, previous tibial condyle/plateau fractures, deformity, or revision of prior arthroplasty. Intended for cemented use only.

Regulatory Classification

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).

Predicate Devices

• Repicci II Unicompartmental Knee (K971938)
• Zimmer Unicompartmental Knee System (K033363)
• Miller /Galante Precoat Unicompartmental Knee (K010685)
• EIUS Unicompartmental Knee System (K033769)
• Active Unicompartmental Kncc System (K060412)
• Repicci II Unicondylar Knee System (K020264)

Submission Summary (Full Text)

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K072704 # '12

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## 510(K) SUMMARY 3.

Valpo Orthopedic Technology, Inc. Applicant/Sponsor: 1. 438 E 200 N Warsaw, IN 46582

- പ്പ് 5 3 9 Contact Person: Hans Stover 2. President & CEO [e-mail] Phone [phone], Ext 222
- 3. Proprietary Name: Unicompartmental Knee
- Common Name: Unicondylar Knee 4.
- Classification Name: 5. Knee joint, femorotibial metal/polymer semi-constrained cemented Prosthesis (21 CFR 888.3530)

6. Legally Marketed Devices to which Substantial Equivalence is Claimed:

- Repicci II Unicompartmental Knee. (K971938) ત્વા
- Zimmer Unicompartmental Knee System (K033363) b.
- Miller /Galante Precoat Unicompartmental Knee (K010685) C.
- d. EIUS Unicompartmental Knee System -(K033769)
- Active Unicompartmental Kncc System-(K060412) .3
- f. Repicci II Unicondylar Knee System-(K020264)
- 7. Device Description:

The VOT Uni Knec consists of a femoral and a tibial component. The low profiled prosthesis is designed to be nonconstraining and to allow natural weight distribution and

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flexion. The anatomically designed femoral component is asymmetrically shaped conforming to the natural knee in the coronal and sagittal planes. The post and keel are designed to provide anteroposterior and mediolateral stability. Cobalt Chrome Alloy is used to fabricate the component which is available in three sizes. The tibial component is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPe). It incorporates a hemispherical shaped articular surface to replicate the natural knce. The component is nonconstraining and designed to allow natural weight distribution and flexion. Dovetailed channels on the undersurface allow for mechanical lock between the implant and the cement mantle. The thickness of the component under the area of the femoral-tibial articulation helps to improve longevity and to minimize the possibility of its fracture. The dual injection ports, the cement delivery instruments, synnge and adapter facilitate cement application. Nine sizes are available to enhance surgical latitude in preoperative planning. Tibial and femoral instruments and trials are also available to facilitate implantation.

The VOT Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knec when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. The device is intended for cement use only.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 19 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Valpo Orthopedic Technology, Inc. % Mr. Hans Stover President & CEO 438 E 200 N Warsaw, Indiana 46582

Re: K072704 Trade/Device Name: Unicompartmental Knee Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint, femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: January 24, 2008 Received: January 25, 2008

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 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 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.

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## Page 2 - Mr. Hans Stover

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 [phone]. 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 Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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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| 2. | INDICATIONS FOR USE |
|----|---------------------|
|----|---------------------|

| 510(k) Number (if known): | N/A (unknown) K072704 |
|---------------------------|-----------------------|
| Device Name: | Unicompartmental Knee |

Indications for Use:

The Unicompartmental Knee is indicated for:

The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. This device is intended for cemented use only.

| Prescription Use | X | AND/OR | Over-The-Counter Use |
|-----------------------------|---|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divison Sign-Off) 1 (Division Sign-On)
Division of General, Restorative,
Division of General, Devices Division of Secon Devices X072704 510(k) Number_________________________________________________________________________________________________________________________________________________________________