PROCLASS PRESS FIT HIP STEM

K032110 · Stelkast Company · LWJ · Sep 22, 2003 · Orthopedic

Device Facts

• Record ID: K032110
• Device Name: PROCLASS PRESS FIT HIP STEM
• Applicant: Stelkast Company
• Product Code: LWJ · Orthopedic
• Decision Date: Sep 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis. The stem can be used for primary hip implant or for hip revision of a failed implant. The stem can be used for congenital defects that will allow adequate function of the system.

Device Story

ProClass Press Fit Hip Stem is a cementless femoral component for hip arthroplasty. Device replaces articulating surface of femur in patients with severe hip disability or pain. Used in primary or revision hip surgery. Implanted by orthopedic surgeons in clinical/hospital settings. Provides structural support for hip joint, restoring function and reducing pain. Device design facilitates press-fit fixation within femoral canal.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cementless femoral hip stem; metallic construction; designed for press-fit fixation; single-use; non-sterile (implied, requires sterilization per standard practice).

Indications for Use

Indicated for patients requiring hip reconstruction due to osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or femoral head fracture, and for primary or revision hip arthroplasty or congenital defects, provided sufficient sound bone exists for prosthesis seating.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2003

Mr. Donald A. Stevens President StelKast Company 200 Hidden Valley Road McMurray, Pennsylvania 15317

Re: K032110 Trade/Device Name: ProClass Press Fit Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LWJ, LZO Dated: June 30, 2003 Received: July 9, 2003

Dear Mr. Stevens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The f general controls 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Donald A. Stevens

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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): K032110

Device Name: ProClass Press Fit Hip Stem

## Indications For Use:

- 1. The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis.
- 2. The stem can be used for primary hip implant or for hip revision of a failed implant.
- 3. The stem can be used for congenital defects that will allow adequate function of the system.

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Concurrence of CDRH, Office of Device Evaluation (OI Division Sign-· Pestorative Division of Gent

and Neurologica

510(k) Number K032110

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

(Optional Format 1-2-96)