OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT

K973406 · Osteonics Corp. · JWH · Dec 8, 1997 · Orthopedic

Device Facts

• Record ID: K973406
• Device Name: OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
• Applicant: Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 8, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation.

Device Story

The Osteonics Series 7000 Total Knee Augmented Femoral Component is a prosthetic implant designed for total knee arthroplasty. It features a posterior stabilizing housing, intercondylar cam, fixed intramedullary stem, and a waffled interior surface. The device includes distal and posterior build-ups on the interior to compensate for femoral bone loss. It is intended for single-use, cemented fixation. The device is implanted by a surgeon during knee replacement surgery to replace the articulating surface of the distal femur. It provides structural support and joint stability in patients with significant bone loss or ligamentous deficiency. The optional nitrogen ion implanted bearing surface treatment (LFIT) may be applied. The device functions as a mechanical replacement for the distal femur, restoring joint function and alleviating pain associated with disabling knee disease.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Prosthetic knee component; metal/polymer construction; posterior stabilizing housing; intercondylar cam; fixed intramedullary stem; waffled interior surface; optional nitrogen ion implanted bearing surface treatment (LFIT); cemented fixation; single-use.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (degenerative, rheumatoid, or post-traumatic arthritis) complicated by bone loss; post-traumatic loss of joint configuration/function; moderate varus, valgus, or flexion deformity with restorable ligamentous stability; revision of previous unsuccessful knee procedures with bone loss; ligamentous instability requiring increased constraint; or absent/non-functioning posterior cruciate ligament.

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

• Osteonics® Series 7000 Total Knee Posteriorly Stabilized Long Stem Femoral Component

Submission Summary (Full Text)

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K973406

Osteonics" Series 7000 Total Knee Augmented Femoral Component

510(k) Premarket Notification

# 510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

DEC - 8 1997

# OSTEONICS® SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT

## Submission Information Name and Address of the Sponsor of the 510(k) Submission:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Regulatory Affairs Specialist

Contact Person:

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name:

Classification Name and Reference:

September 8, 1997

Donna S. Wilson

Osteonics® Series 7000 Total Knee Augmented Femoral Component

Knee Prosthesis

Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis; 21 CFR §888.3560

#### Predicate Device Identification

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is substantially equivalent to the Osteonics® Series 7000 Total Knee Posteriorly Stabilized Long Stem Femoral Component.

### Device Description

The Osteonics® Series 7000 Total Knee Augmented Femoral Component features a posterior stabilizing housing, intercondylar cam, fixed intramedullary stem, waffled interior surface pattern, optional nitrogen ion implanted bearing surface treatment (LFIT™), and a distal and posterior build-up on the interior of the component to compensate for femoral bone loss.

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#### Intended Use

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation.

## Statement of Technological Comparison

The Osteonics® Series 7000 Total Knee Augmented Femoral Component shares the same materials, indications and intended use, and basic design features of the predicate devices. Applicable performance testing demonstrates that no significant difference exists between this component and the predicate designs.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 8 1997

Ms. Donna S. Wilson Requlatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K973406 Re : Osteonics Series 7000 Total Knee Augmented Femoral Component Requlatory Class: II Product Code: ਹੈਕਸ September 8, 1997 Dated: Received: September 9, 1997

Dear Ms. Wilson:

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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

- 1. This device may not be labeled or promoted for noncemented use.
- 2. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
- 3. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) requlation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

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Page 2 - Ms. Donna S. Wilson

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 genera Other general information on your responsibilities under the Act may be

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Page 3 - Ms. Donna S. Wilson

obtained from the Division of Small Manufacturers Assistance obtained from the Division of Small March [phone] or at
at its toll-free number [phone] or [phone] or at at its toll-free number [phone] Of (600) do 100 homemain.itml".
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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# 510(k) Number (if known): K973406

# Device Name: Osteonics® Series 7000 Total Knee Augmented Femoral Component

#### Intended Use:

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation. The indications for use are:

- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss.
- . 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, accompanied by . bone loss.
- Ligamentous 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) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K973406 |
| Prescription Use (Per 21 CFR 801.109) | X |
| | OR |
| Over-The-Counter Use | _ |

(Optional Format 1-2-96)