FS 1000 KNEE SYSTEM

K991052 · Renaissance Instruments, LLC · JWH · Nov 10, 1999 · Orthopedic

Device Facts

• Record ID: K991052
• Device Name: FS 1000 KNEE SYSTEM
• Applicant: Renaissance Instruments, LLC
• Product Code: JWH · Orthopedic
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis; - Inflammatory degenerative joint disease including rheumatoid arthritis; - Correction of varus, valgus, or post traumatic deformity; - Correction or revision of unsuccessful osteotomy or arthrodesis; - Revision procedures where other treatments or devices have failed; and - Treatment of fractures that are unmanageable using other techniques;

Device Story

FS 1000 Knee System is a total knee arthroplasty implant designed for single-use cemented implantation. Used by orthopedic surgeons in hospital settings to replace damaged knee joint surfaces. Device components provide mechanical stability and articulation to reduce pain and restore function in patients with degenerative joint disease, deformities, or fractures. Clinical benefit derived from restoring joint mechanics and alleviating symptoms associated with knee pathology. System functions as a structural replacement; no electronic or software components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Total knee arthroplasty system for cemented implantation. Mechanical implant design; no energy source, connectivity, or software. Materials and sterilization methods are consistent with standard orthopedic implant requirements for Class II devices.

Indications for Use

Indicated for skeletally mature patients undergoing total knee arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), deformity correction (varus, valgus, post-traumatic), revision of failed osteotomy/arthrodesis, revision of failed prior devices, or treatment of fractures unmanageable by other techniques.

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).

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 0 1999

Kent M. Samuelson, M.D. Regulatory Affairs Representative Renaissance Instruments, LLC 370 Ninth Avenue, Suite 205 Salt Lake City, Utah 84103

Re: K991052 FS 1000 Knee System Trade Name: Requlatory Class: II Product Code: JWH Dated: August 25, 1999 Received: August 26, 1999

Dear Dr. Samuelson:

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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.

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## Page 2 - Mr. Craig Corrance

This letter will allow you to begin marketing your device as inis iceci will and the premarket notification. The FDA asboing of substantial equivalence of your device to a legally IInding of Subscanelar equits in a classification for your marketed predicate and the 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 regarddagnostic devices), please contact the Office of victo diagnobels at (301) 594–4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the orrios or compiland, "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,

[signature]

James E. Dillard III Acting 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 991052

K991052

Device Name: FS 1000 Knee System

## Indications for Use

The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

- Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic ● arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; ●
- Correction of varus, valgus, or post traumatic deformity; ●
- Correction or revision of unsuccessful osteotomy or arthrodesis; ●
- . Revision procedures where other treatments or devices have failed; and

OR

- . Treatment of fractures that are unmanageable using other techniques;
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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Taseer To

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)