PROTRACT PRESS FIT HIP STEM

• K Number: K003447
• Device Name: PROTRACT PRESS FIT HIP STEM
• Manufacturer: STELKAST COMPANY
• Date Cleared: 2000-12-15 ( 39 days)
• Product Code: LPH
• Regulation Number: 888.3358
• Type: Traditional
• Panel: Orthopedic
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
2. Revision of failed femoral head replacements.
3. When alternative reconstructive techniques are not viable.
4. When arthrodesis is contraindicated.
5. Avascular necrosis or fracture of the femoral head.
6. Congenital defects that will allow adequate function of the system.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study details for the "Protract Press Fit Hip Stem" device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device already on the market. It lists the indications for use but does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes, data provenance, or expert qualifications for a test set.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or the sample size and ground truth establishment for a training set.

The FDA letter grants market clearance based on substantial equivalence, and typically, the detailed performance data from such studies would be found in the 510(k) submission itself, not in the clearance letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2000

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

Re: K003447

Trade Name: Protract Press Fit Hip Stem Regulatory Class: II Product Code: LPH Dated: November 3, 2000 Received: November 6, 2000

Dear Mr. Stevens:

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 of the Act. The 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 HI (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 regulation 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.

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.

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Page 2 - Mr. Donald A. Stevens

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and n you active specific and in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, [phone] - Additions 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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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510(K) Number (if known):

K00347

Device Name: Protract Press Fit Hip Stem

Indications For Use:

• 1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
• 2. Revision of failed femoral head replacements.
• 3. When alternative reconstructive techniques are not viable.
• 4. When arthrodesis is contraindicated.
• 5. Avascular necrosis or fracture of the femoral head.
• 6. Congenital defects that will allow adequate function of the system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Milluson

(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

:

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

N/A