CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

K983141 · Johnson & Johnson Professionals, Inc. · JDB · Nov 6, 1998 · Orthopedic

Device Facts

• Record ID: K983141
• Device Name: CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JDB · Orthopedic
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.

Device Story

Total elbow prosthesis; semi-constrained design; relies on patient's native soft tissue (medial collateral ligament, triceps tendon) for stability and force absorption. Humeral component: cobalt-chromium-molybdenum (Co-Cr-Mo) alloy with intramedullary stem. Ulnar component: Co-Cr-Mo with ultra-high molecular weight polyethylene (UHMWPE) articulating surface. Intended for cemented fixation in surgical setting. Replaces damaged joint surfaces to alleviate pain and restore motion in patients with rheumatoid arthritis, posttraumatic conditions, or osteoarthritis.

Clinical Evidence

Bench testing only. Evaluation of calcium stearate-free UHMWPE confirmed material meets or exceeds specifications; mechanical and functional testing demonstrated performance equivalent or superior to existing UHMWPE.

Technological Characteristics

Semi-constrained cemented elbow prosthesis. Materials: Cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and ultra-high molecular weight polyethylene (UHMWPE). Design relies on native soft tissue for stability. Intramedullary stem for humeral fixation.

Indications for Use

Indicated for elbow arthroplasty in patients with rheumatoid arthritis (intractable pain, limited motion, radiographic destruction, preserved bony stock) or older patients with posttraumatic or osteoarthritic conditions and low activity levels. Intended for cemented use.

Regulatory Classification

Identification

An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial 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).

Predicate Devices

• Pre-Amendment Capitello-Condylar Elbow System

Submission Summary (Full Text)

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6 1998 NOV

K98314/

510K Summarv Capitello-Condylar Total Elbow Prosthesis November 2, 1998

## 1. Submitter

Johnson & Johnson Professional, Inc. 325 Paramount Drive Ravnham, MA 02767 Deana Boushell, Regulatory Affairs Specialist, [phone]

## Device Name 2.

| Proprietary Name: | Capitello-Condylar Total Elbow Prosthesis |
|----------------------|----------------------------------------------------------------|
| Common Name: | Elbow Prosthesis |
| Classification Name: | Elbow joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class: | Class II, per CFR § 888.3160 |

## 3. Intended Use

The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.

## 4. Device Description

The Captiello-Condylar Total Elbow Prosthesis is an elbow replacement which relies on existing soft tissue structures such as the medial collateral ligament and triceps tendon for support and stability. The Humeral component is composed of cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and has an intramedullary stem for fixation. The Ulnar component is composed of Co-Cr-Mo, with an articulating surface of ultra-high molecular weight polyethylene (UHMWPE). The device is designed to rely on soft tissue structures to support and absorb the forces which would otherwise be transmitted to the prosthesis, cement, or bone. The device is intended for use with bone cement.

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## 5. Predicate Device Comparison

The Capitello-Condylar Total Elbow Prosthesis is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the Pre-Amendment Capitello-Condylar Elbow System. Modifications to the UHMWPE used in the manufacture of some of the system components do not represent a significant change to the safety and effectiveness of the device.

#### Device Testing Summary 6.

Extensive evaluation testing of the calcium stearate free UHMWPE indicates that the material meets or exceeds all current specifications for the material. In addition, results of both mechanical property and device function testing show that the material performs as well as or better than the UHMWPE currently being used.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 6 1998

Deana M. Boushell, RAC Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts

Re: K983141 Capitello-Condylar Total Elbow Prosthesis Regulatory Class: II Product Code: JDB September 4, 1998 Dated: Received: September 8, 1998

Dear Ms. Boushell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Deana M. Boushell, RAC

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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K783/41

# Capitello-Codylar Total Elbow Prosthesis INDICATIONS FOR USE

The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off)
Division of General Restorative Devices L983141

法

S Prescription Use (Per 21 CFR §801.109)

OR

510(k) Number

Over-the-Counter Use _No

(Optional Format 1-2-96)