IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY

K983128 · Implex Corp. · JDI · Dec 3, 1998 · Orthopedic

Device Facts

• Record ID: K983128
• Device Name: IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
• Applicant: Implex Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as an in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.

Device Story

Implex Hedrocel® Replacement Cup Insert is a cemented polyethylene bearing surface component for acetabular hip prostheses. Designed for in-situ replacement within existing Hedrocel® acetabular cups (OD 40-70 mm). Available in four ID sizes (22, 26, 28, 32 mm) and three face angles (0°, 10°, 20°). Used by orthopedic surgeons in clinical settings to address joint instability, wear, or damage of the original bearing surface. Provides a replacement articulating surface to restore hip joint function and stability.

Clinical Evidence

Bench testing only; fatigue characteristics evaluated under defined laboratory conditions.

Technological Characteristics

Polyethylene bearing surface; cemented fixation; compatible with Hedrocel® acetabular cups (40-70 mm OD); ID sizes 22-32 mm; face angles 0°, 10°, 20°.

Indications for Use

Indicated for patients requiring in-situ replacement of a polyethylene bearing surface in an acetabular cup due to joint instability, wear, or damage.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Implex Hedrocel® Porous Acetabular Cup System
• Implex Replacement Acetabular Cup Insert System
• Osteonics GAP II Restoration Acetabular shell with Omnifit® Polyethylene Insert Bearing

Submission Summary (Full Text)

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## K983128

## IMPLEX Hedrocel® Replacement Cup Insert, Cemented

| 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: | September 3, 1998 |
| Device Trade Name: | Implex Hedrocel® Replacement Cup Insert |
| Device Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, Hip, Acetabular Component, Cemented |
| Predicate Devices: | Implex Hedrocel® Porous Acetabular Cup System, Implex<br>Replacement Acetabular Cup Insert System, Osteonics GAP II<br>Restoration Acetabular shell with Omnifit® Polyethylene Insert<br>Bearing. |
| Device Description: | The Implex Hedrocel® Replacement Cup Inserts, cemented, are<br>compatible with the family of Hedrocel® acetabular cups in OD<br>sizes from 40 to 70 mm. The replacement inserts are available<br>with four ID size options (22 mm, 26 mm, 28 mm and 32 mm)<br>and in 0°, 10°, and 20° face angles. |
| Intended Use: | The Implex Hedrocel® Replacement Cup Insert, cemented, is<br>intended for use as a <i>in-situ</i> replacement polyethylene bearing<br>surface under circumstances of joint instability, wear and/or<br>damage caused by the patient during use. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device: | A comparison of the principal device technological<br>characteristics to the predicate devices demonstrates that the<br>bearing surface is substantially equivalent to commercially<br>available polyethylene bearing surfaces |
| Performance Data: | Testing conducted to evaluate the fatigue characteristics of<br>the device under defined laboratory conditions was<br>provided to support a finding of substantial equivalence. |
| Conclusion: | The Implex Hedrocel® Replacement Cup Insert is<br>substantially equivalent to the identified predicate devices. |

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and the comments of the comments of

11:10 PM

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Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized image of three human profiles facing right, with flowing lines representing movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1998

John A. Schalago, RAC Regulatory Affairs Manager Implex Corporation 80 Commerce Drive 07401-1600 Allendale, New Jersey

K983128 Re: Implex Hedrocel® Replacement Cup Insert Trade Name: Requlatory Class: II Product Code: JDI Dated: September 4, 1998 Received: September 8, 1998

Dear Mr. Schalago:

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 Regulations, 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 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 - John A. Schalago, 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

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):

K983128

Device Name:

Implex Hedrocel® Replacement Cup Insert

Indications For Use:

The Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as an in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.

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| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR...

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

| (Optional Format 1-2-96) | |
|--------------------------|--|
|--------------------------|--|

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983128 |

Concurrence of CDRH; Office of Device Evaluation (ODE)