ASCENT KNEE SYSTEM

K991428 · Biomet, Inc. · JWH · May 21, 1999 · Orthopedic

Device Facts

• Record ID: K991428
• Device Name: ASCENT KNEE SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: May 21, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to noninflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement

Device Story

Ascent Knee System consists of independent Ti-6Al-4V femoral augments; designed to replace damaged or diseased knee bone. Device functions as semi-constrained cemented prosthesis; intended for use with bone cement. Used in surgical setting by orthopedic surgeons to restore joint function and relieve pain in patients with degenerative joint disease or rheumatoid arthritis. Output is physical replacement of bone structure; clinical decision-making based on patient need for joint reconstruction. Benefits include pain relief and restored mobility.

Clinical Evidence

No clinical data provided; substantial equivalence based on design modifications to a predicate device.

Technological Characteristics

Material: Ti-6Al-4V. Type: Semi-constrained cemented knee prosthesis. Form factor: Femoral augments. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring relief of pain and restoration of motion due to non-inflammatory degenerative joint disease, rheumatoid arthritis, knee deformities, or revision of failed knee replacements. Requires use with bone cement.

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

• Performance Knee (not specifically numbered)

Submission Summary (Full Text)

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MAY 21 1938

## SUMMARY OF SAFETY AND EFFECTIVENESS

### Biomet, Inc. Sponsor: Airport Industrial Park P.O. Box 587 Warsaw, IN 4681-0587

Ascent Knee System Device:

Classification: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (CFR 888.3560)

Device Description: The Ascent Knee System has independent Ti-6A1-4V femoral augments which are designed to replace damaged or diseased knee bone. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative ioint disease, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but not limited to:

- Reaction to bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/Migration Tissue growth failure
- Blood vessel damage Soft tissue imbalance Delayed would healing Metal sensitivity Fracture of the components Nerve damage
- Bone fracture Infection Hematoma Dislocation Excessive wear

Modifications made were to the Performance Knee femoral augment to produce the Ascent Knee femoral augments.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 1999

Ms. Dalene Hufziger Binkley Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

Re: K991428 Ascent Knee System Trade Name: Regulatory Class: II Product Code: JWH Dated: April 23, 1999 Received: April 26, 1999

Dear Ms. Binkley:

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 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 - Ms. Dalene Hufziger Binkley

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,

Russell P. Vayr

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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Page 1 of 1

510 (k) NUMBER (IF KNOWN): ____

DEVICE NAME: Ascent Knee System ______________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to noninflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements.

Standard surgical and rehabilitative procedures are indicted with this device.

This device is for use with bone cement

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
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| (Division Sign-Off) Division of General Restorative Devices | |
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| 510(k) Number | K991428 |

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