OSTEONICS SERIES 7000 AD TIBIAL TRAY

K983657 · Osteonics Corp. · HRY · Apr 6, 2000 · Orthopedic

Device Facts

• Record ID: K983657
• Device Name: OSTEONICS SERIES 7000 AD TIBIAL TRAY
• Applicant: Osteonics Corp.
• Product Code: HRY · Orthopedic
• Decision Date: Apr 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Howmedica Osteonics® Series 7000 AD Tibial Tray is intended to be marketed for cemented fixation only and may be used with any of the following UHMWPE tibial bearing inserts, which range in thickness from 8mm to 24mm: - · Howmedica Osteonics Tibial Bearing Insert Series I - Howmedica Osteonics® Tibial Bearing Insert Series II ● - · Howmedica Osteonics® Series 7000 Total Knee Tibial Bearing Insert Series P/S- I - Howmedica Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert . - Howmedica Osteonics® Scorpio Total Knee Cruciate Retaining Tibial Bearing Insert . If supplemental bone screw fixation of the tray is deemed necessary, Howmedica Osteonics® 6.5mm Cancellous Bone Screws may be placed through the tibial tray screw holes.

Device Story

Total knee tibial component for cemented fixation; replaces knee joint surfaces. Metallic tray (ASTM F75-92 CoCr alloy) features "pocketless" design with roughened, arc-deposited CP Titanium coating (ASTM F67-95) on fixation surface; keeled stems have satin finish. Used with compatible UHMWPE tibial bearing inserts (8-24mm thickness). Optional 6.5mm cancellous bone screws for supplemental fixation. Used in orthopedic surgery; implanted by surgeons. Provides stable platform for knee reconstruction; restores joint function; alleviates pain from arthritis or deformity.

Clinical Evidence

Bench testing only. Substantial equivalence demonstrated through design comparison, material characterization, and coating characterization summary.

Technological Characteristics

Materials: ASTM F75-92 CoCr alloy substrate; ASTM F67-95 CP Titanium arc-deposited coating; LDPE screw hole plugs. Design: Pocketless tibial tray with keeled stem. Fixation: Cemented. Sterilization: Standard methods.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (degenerative, rheumatoid, or post-traumatic arthritis); post-traumatic loss of knee joint configuration/function; moderate varus, valgus, or flexion deformity with functional ligamentous structures; or revision of unsuccessful knee replacement. Posterior stabilized components indicated for ligamentous instability requiring increased constraint or absent/non-functioning posterior cruciate ligament. Contraindicated in patients with active/latent infection, mental/neuromuscular disorders causing instability/fixation failure, compromised bone stock, skeletal immaturity, severe collateral ligament instability, or obesity.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Howmedica Osteonics® Series 7000 Total Knee System Tibial Components
• Howmedica Osteonics® Omniflex™ AD Hip Stem
• The Maxim® Complete Knee System - Biomet, Inc.

Submission Summary (Full Text)

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K983657

Howmedica Osteonics Scries 7000 AD Tibial Tray

## 510(k) Premarket Notification Summary of Safety and Effectiveness for the Howmedica Osteonics® Series 7000 AD Tibial Tray

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677 | |
|--------------------------------------------------------------|----------------------------------------------------------------------|--|
| Contact Person: | Mary-Catherine Dillon<br>Regulatory Affairs Specialist | |
| Date of Summary Preparation:March 31, 2000 | | |
| Device Identification | | |
| Proprietary Name: | Howmedica Osteonics® Series 7000<br>AD Tibial Tray | |
| Common Name: | Total Knee Tibial Component | |
| Classification Name and Reference: | Knee Joint Femorotibial<br>Metal/Polymer Semi-Constrained | |

#### Predicate Device Identification

The Howmedica Osteonics® Series 7000 AD Tibial Tray is substantially equivalent to the following competitive and/or Howmedica Osteonics devices, which have previously been determined substantially equivalent by FDA:

Cemented Prosthesis 21 CFR 888.3530

- Howmedica Osteonics® Series 7000 Total Knee System Tibial Components ●
- . Howmedica Osteonics® Omniflex™ AD Hip Stem
- . The Maxim® Complete Knee System - Biomet, Inc.

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#### Device Description

Howmedica Osteonics® Series 7000 AD Tibial Trays are intended for cemented fixation on the prepared proximal tibia and are designed to achieve total reconstructive replacement of the knee joint when used in conjunction with the Howmedica Osteonics® Total Knee Femoral, Patellar and Tibial Insert Components. The metallic tibial tray is manufactured from ASTM F75-92 CoCr alloy. The "pocketless" design of the fixation surface employs a roughened, arc-deposited ASTM F67-95 CP Titanium coating. The keeled stems of the Howmedica Osteonics® Series 7000 AD Tibial Tray employ a satin finish and are not coated with arc-deposited CP Titanium. Screw hole plugs, fabricated from low density polyethylene (LDPE), are located in the tibial tray screw holes.

#### Intended Use:

The Howmedica Osteonics® Series 7000 AD Tibial Tray is intended to be marketed for cemented fixation only and may be used with any of the following UHMWPE tibial bearing inserts, which range in thickness from 8mm to 24mm:

- · Howmedica Osteonics Tibial Bearing Insert Series I
- Howmedica Osteonics® Tibial Bearing Insert Series II ●
- · Howmedica Osteonics® Series 7000 Total Knee Tibial Bearing Insert Series P/S- I
- Howmedica Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert .
- Howmedica Osteonics® Scorpio Total Knee Cruciate Retaining Tibial Bearing Insert .

If supplemental bone screw fixation of the tray is deemed necessary, Howmedica Osteonics® 6.5mm Cancellous Bone Screws may be placed through the tibial tray screw holes.

#### Indications:

- · Painful, disabling joint discase of the knee resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned . to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. ●
- Additional Indications for Posterior Stabilized Components:
- Ligmentous instability requiring implant bearing surface geometries with increased constraint. .
- . Absent or non-functioning posterior cruciate ligament.

#### Contraindications:

The contraindications for the Howmedica Osteonics® Series 7000 AD Tibial Tray include:

- · Any active or suspected latent infection in or about the knee joint.
- Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- . Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.

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- . Skeletal immaturity.
- · Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- . Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself.

#### Statement of Technological Comparison:

The subject device is identical to the tibial tray of the predicate Howmedica Osteonics® Series 7000 Total Knee Tibial Components in all material and design aspects, indications, shape and intended use, with the exception of the arc-deposited CP Titanium coating and the absence of a "pocket" on the inferior side of the tray. The arc-deposited CP Titamium coating on the inferior side of the tibial tray is identical to the AD coating on the predicate Howmedica Osteonics® Omniflex™ AD Hip Stem.

Howmedica Osteonics' CP Titanium coating is arc-deposited onto the surface of CoCr substrate. The combination of a CoCr substrate with CP Titanium coating on the Howmedica Osteonics® Series 7000 AD Tibial Tray is similar to that of the predicate Maxim® Complete Knee System manufactured by Biomet, Inc., which offers a CoCr substrate coated with Titanium alloy.

#### Summary

Based on the information presented above in combination with a Coating Characterization Summary, and the fact that the Howmedica Osteonics® Series 7000 AD Tibial Trays employ standard sterilization and packaging methods, the substantial equivalence of the Howmedica Osteonics® Series 7000 AD Tibial Trays to other legally marketed, class II total knee components is demonstrated.

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in all capital letters.

APR 6 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary-Catherine Dillon Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K983657

Trade Name: Howmedica Osteonics® Series 7000 AD Tibial Trav Regulatory Class: II Product Code: HRY and JWH Dated: January 24, 2000 Received: January 28, 2000

Dear Ms. Dillon:

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 control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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.

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Page 2 - Ms. Mary-Catherine Dillon

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Dune R. Lochner.

Colia 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): K_983657

### Device Name: Howmedica Osteonics® Series 7000 AD Tibial Trav

Indications For Use:

The subject devices are single use components, intended for cemented use only. The indications for the use of these tibial trays, in keeping with those of other legally marketed Howmedica Osteonics tibial trays, are as follows:

Indications:

- . Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function.
- . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- . Revision of previous unsuccessful knee replacement or other procedure.

Additional Indications for Posterior Stabilized Components:

- . Ligmentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | <div align="center"><u>Dunne R. Vochnes</u></div> <div align="center">(Division Sign-Off)</div> | |
| | Division of General Restorative Devices | |
| 510(k) Number | K983657 | |
| Prescription Use <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use <span style="text-decoration: overline;"></span> |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |