MODIFICATION TO PROVIDENT HIP SYSTEM

K002796 · Stelkast Company · LWJ · Sep 28, 2000 · Orthopedic

Device Facts

• Record ID: K002796
• Device Name: MODIFICATION TO PROVIDENT HIP SYSTEM
• Applicant: Stelkast Company
• Product Code: LWJ · Orthopedic
• Decision Date: Sep 28, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Hip arthritis caused by rheumatoid disease, noninflammatory degenerative joint disease, or from biologic or mechanical trauma to the hip. 2. Correction of functional deformity. 3. Treatment of nonunions, femoral neck and trochanteric fractures of the proximal femur. 4. Difficult clinical management problems involving persistent pain and physical impairment where conventional arthrodesis is not likely to achieve satisfactory results.

Device Story

Provident Hip System is a hip prosthesis used for total hip arthroplasty. It replaces damaged or diseased hip joint components to restore function and alleviate pain. The device is implanted by an orthopedic surgeon in a clinical/hospital setting. It functions as a mechanical replacement for the femoral head and/or acetabulum. The system is intended for patients suffering from arthritis, fractures, or nonunions. Clinical benefit includes pain relief, correction of deformity, and restoration of joint mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hip prosthesis system. Materials and design are consistent with standard orthopedic hip implants. Mechanical fixation/articulation principle. No software or electronic components.

Indications for Use

Indicated for patients with hip arthritis (rheumatoid, noninflammatory degenerative, or trauma-induced), functional deformity, nonunions, or proximal femur fractures (femoral neck/trochanteric) requiring hip arthroplasty due to persistent pain or physical impairment where arthrodesis is unsatisfactory.

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.

Predicate Devices

• K935484
• K001745

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 8 2000

Mr. Donald A. Stevens President StelKast Company 800, Vinial Street Suite B-210 Pittsburgh, Pennsylvania 15212

Re: K002796

Trade Name: Provident Hip System Regulatory Class: II Product Code: LWJ Dated: September 6, 2000 Received: September 7, 2000

Dear Mr. Stevens:

We have reviewed your Section 510(k) notification of intent to market the device referenced w thate reviewed four beened 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 stared in and oneroune) to the Medical Device Amendments, or to devices that have been reclassified in enacinent 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 thereolo, mainon of the Act include requirements for annual registration, listing of devices, control provisions of the 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 (Tremancer ripproval), 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 mspoticility ato I and 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 I ntis letter . It and ny 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 - Mr. Donald A. Stevens

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific days of the size ostic devices), please contact the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, [phone]. Trudinonally, 101 quest at [phone]. Also, please note the regulation
(1) 101 picase condon the Orifica or Sompilars of emarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small milliation on your responsibilities and more [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html" .

Sincerely yours,

Mark N. Millerson

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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Koo>796

n): K935484 and K001745

# 510(K) Number (if known):

### Special 510(k) Device Modification Device Name: Provident Hip System

## Indications For Use:

- 1. Hip arthritis caused by rheumatoid disease, noninflammatory degenerative joint ITIP artifitis baused of them from biologic or mechanical trauma to the hip.
- 2. Correction of functional deformity.
- 3. Treatment of nonunions, femoral neck and trochanteric fractures of the proximal femur.
- 4. Difficult clinical management problems involving persistent pain and physical impairment where conventional arthrodesis is not likely to achieve satisfactory results.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
Mark N Milkers
(Division Sign-Off)
Division of General Restorative Devices
K 0027

Division of
510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

**Over-The-Counter Use** No

(Optional Format 1-2-96)