FANNING-PAPPAS MODULAR KNEE BEARING

K081400 · Endotec, Inc. · JWH · Feb 20, 2009 · Orthopedic

Device Facts

• Record ID: K081400
• Device Name: FANNING-PAPPAS MODULAR KNEE BEARING
• Applicant: Endotec, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis, in knees having coirectable mity, and viable or reconstructable ligaments. valgus or var ..

Device Story

Fenning-Pappas Modular Knee Bearing is a knee joint patellofemorotibial polymer semi-constrained cemented prosthesis. Used by orthopedic surgeons in clinical settings for total knee arthroplasty or revision procedures. Device replaces damaged joint surfaces to restore function and reduce pain in patients with severe knee pathology. Operates as a mechanical implant; provides structural support and articulation for the knee joint. Clinical benefit includes improved mobility and pain relief for patients with degenerative or traumatic joint disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis. Class II device. Product code JWH. Mechanical implant design.

Indications for Use

Indicated for patients requiring reconstruction or revision of painful/severely disabled knee joints due to osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or failed prior prosthesis. Requires correctable deformity and viable/reconstructable ligaments.

Regulatory Classification

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).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & 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

Endotec, Inc. % Michael J. Pappas, Ph.D., P.E. President 2546 Hansrob Road Orlando, Florida 32804

Re: K081400

Trade/Device Name: Fenning-Pappas, Modular Knee Bearing

Regulation Number: 21 CFR 888.3560

Regulation Name ... Knee joint patellofemorotibial polymer semi-constrained cernented prosthesis

FEB 2009

Regulatory Class: II Product Code: JWH Dated: December 1, 2008 Received: December 4, 2008

Dear Dr. Papps:

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 - Michael J. Pappas, Ph.D., P.E.

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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

urs,

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

Enclosure

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# INDICATIONS FOR USE

### 510(k) Number: K081400

Device Name: Fenning-Pappas, Modular Knee Bearing

### Indications for Use:

The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis, in knees having coirectable mity, and viable or reconstructable ligaments. valgus or var ..

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation@@DE)

510(k) Number

(Division Si-Off)
Division of General, Restorative,
and Neurogical Devices

LO81962