IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA

K983835 · Implex Corp. · JWH · Mar 15, 1999 · Orthopedic

Device Facts

• Record ID: K983835
• Device Name: IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
• Applicant: Implex Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis. This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.

Device Story

Modular porous-backed patellar prosthesis; consists of Hedrocel® backing with titanium alloy suture ring; used as component of Continuum Knee System. Designed for augmenting patellar defects during knee revision surgery. Implanted by orthopedic surgeons in clinical/OR settings. Utilizes bone cement for fixation; includes optional supplemental suture attachment for additional support. Benefits patients by restoring patellar function in complex revision cases where standard techniques fail.

Clinical Evidence

Bench testing only. Performance supported by design similarities to predicate devices, previously submitted performance data (K882322, K971879), and Hedrocel® material data (MAF #920).

Technological Characteristics

Modular patellar prosthesis; Hedrocel® porous backing; titanium alloy suture ring; articulating surface geometry similar to predicates. Intended for cemented fixation with supplemental suture attachment.

Indications for Use

Indicated for patients requiring patellar replacement due to non-inflammatory degenerative joint disease (osteoarthritis, traumatic arthritis), rheumatoid arthritis, functional deformity, revision of failed prior treatments/devices, unmanageable fractures, or complications from failed prostheses.

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).

Predicate Devices

• Patellar Component of Continuum Knee System (CKS), Implex Corp. (K882322)
• Continuum Porous Patella, Implex Corp. (K971879)
• Konstruct Patellar, Biomet, Inc. (K960856)

Submission Summary (Full Text)

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3/15/99

K98 3835

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## REVISION HEDROCEL® PATELLA

| Submitter Name: | Implex Corp. |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| Contact Person: | Robert Poggie, PhD or John Schalago, RAC |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | October 29, 1998 |
| Device Trade Name: | Continuum Patella-Revision Hedrocel® |
| Device Common<br>Name: | Prosthesis, Patellar |
| Classification Name: | Knee Joint Patellofemorotibial Polymer/Metal/Polymer<br>Semi-Constrained Cemented Prosthesis |
| Predicate Device(s): | Patellar Component of Continuum Knee System<br>(CKS), Implex Corp. (K882322); Continuum Porous<br>Patella, Implex Corp. (K971879), Konstruct Patellar,<br>Biomet, Inc. (K960856) |
| Device Description: | The Revision Hedrocel® Patella is a modular porous<br>backed patella consisting of a Hedrocel® Patellar<br>Backing with titanium alloy suture ring and the current<br>commercially available Continuum® Patella. The<br>Revision Hedrocel® Patella provides the surgeon a<br>method for augmenting defects in the patella typically<br>encountered during revision surgery of the knee. |
| Intended Use: | The Implex Revision Hedrocel® Patella is intended<br>as the patellar component of the Continuum Knee<br>System whose indications for use include: 1)<br>noninflamatory degenerative joint disease including<br>osteoarthritis or traumatic arthritis, 2) rheumatoid<br>arthritis, 3) correction of functional deformity, 4)<br>revision procedures where other treatments or<br>devices have failed, 5) treatment of fractures that are<br>unmanageable using other techniques, and 6) comp- |
| Intended Use<br>(continued) | This device is intended for use with bone cement and<br>supplemental fixation by means of suture attachment.<br>Supplemental suture attachment may be used in<br>cases where additional device support can be<br>obtained. |
| Device<br>Technological<br>Characteristics and<br>Comparison to<br>Predicate Device(s): | The materials, design and articulating surface<br>geometry of the Revision Hedrocel® Patella is similar<br>and/or identical to the claimed predicate devices from<br>Implex Corp. and Biomet Inc. |
| Performance Data: | Based on similarities in design of the Revision<br>Hedrocel® Patella and the predicate devices, the<br>performance testing submitted in K882322 and<br>K971879, and Hedrocel® materials' data found in<br>MAF #920, supports the conclusion that the device<br>will perform as intended. |
| Conclusion: | The Revision Hedrocel® Patella is substantially<br>equivalent to the predicate devices in terms of<br>intended use, safety, and effectiveness. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

K983835 Re: Implex Revision Hedrocel® Patella Trade Name: Regulatory Class: II Product Code: JWH Dated: January 21, 1999 Received: January 22, 1999

Dear Dr. Poggie:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 - Robert A. Poggie, Ph.D.

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 regulation (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. Whitton, Ph.D.

>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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510(k) Number (if known):

K983835

Device Name:

Implex Revision Hedrocel® Patella

Indications For Use:

The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.

This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.

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| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
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Pcolleto

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Division of General Restorative Devices K98382
510(k) Number

Prescription Use (Per 21 CFR 801.109) OR ...

Over-The-Counter Use

μs

(Optional Format 1-2-96)

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