OTI UNICONDULAR INTERPOSITIONAL SPACER

K022779 · Osteoimplant Technology, Inc. · HSH · Nov 20, 2002 · Orthopedic

Device Facts

• Record ID: K022779
• Device Name: OTI UNICONDULAR INTERPOSITIONAL SPACER
• Applicant: Osteoimplant Technology, Inc.
• Product Code: HSH · Orthopedic
• Decision Date: Nov 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amounts of articular cartlige have been lost as a result of the disease. The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following: Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia ) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral components.

Device Story

OTI Unicondular Interpositional Spacer is a metallic resurfacing prosthesis for the knee joint. Device functions as an interpositional implant to address articular cartilage loss in the tibial compartment. Used in orthopedic surgery for uncemented treatment of medial and lateral tibial articulating surfaces. Implant provides a mechanical bearing surface to replace damaged cartilage, potentially reducing pain and improving joint function in patients with moderate knee degeneration. Device is intended for prescription use by orthopedic surgeons.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic resurfacing prosthesis for the knee joint. Designed for uncemented fixation to the tibial articulating surfaces. Classified as a Class II medical device under 21 CFR 888.3590.

Indications for Use

Indicated for patients with osteoarthritic knee exhibiting substantial articular cartilage loss. Specifically for uncemented treatment of medial and/or lateral tibial articulating surfaces in patients with moderate degeneration (grade II-IV chondromalacia) of the medial/lateral compartment and minimal degeneration (grade I-II chondromalacia, no joint space loss) of the patellofemoral components.

Regulatory Classification

Identification

A knee joint tibial (hemi-knee) metallic resurfacing uncemented 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 prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

**NOV 20 2002**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osteoimplant Technology, Inc. Mr. Sam Son Vice President of Technical Affairs 11201 Pepper Road Hunt Valley, Maryland 21031-1201

Re: K022779

Trade/Device Name: OTI Unicondular Interpositional Spacer Regulation Number: 21 CFR 888.3590 Regulation Name: Knee joint tibial (hemi-knee) metallic resurfacing prosthesis Regulatory Class: II Product Code: HSH Dated: August 21, 2002 Received: August 22, 2002

Dear Mr. Son:

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. Sam Son

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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Miriam C. Provost

(c. Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 1025 510(k) Number (if known)_

Device Name: OTI Unicondular Interpositional Spacer System

Indications For Use:

The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amounts of articular cartlige have been lost as a result of the disease.

The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following:

Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia ) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral components.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Prescription Use (Per 21 CFR 801 109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K622779