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

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

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary describes a femoral head replacement device and does not mention any AI or ML components, image processing, or related performance metrics.

Therapeutic

Yes
The device is intended to treat multiple conditions, including arthritis, avascular necrosis, and femoral head fractures, all of which aim to provide therapeutic benefit by restoring function or alleviating symptoms.

Diagnostic

No
The "Intended Use / Indications for Use" section describes conditions that the device treats or is used for (e.g., joint impairment from arthritis, revision of failed femoral head replacements), indicating it is a therapeutic or reconstructive device, not one used for diagnosis.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes a physical implant (femoral head replacement), which strongly suggests a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended uses listed are all related to the surgical treatment of joint impairment and femoral head issues. These are clinical procedures performed on a patient's body, not tests performed on samples taken from the body.
• Device Description: While the device description is "Not Found," the intended uses strongly suggest a physical implant or surgical tool.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.

IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The intended uses described here clearly fall outside of this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

LPH

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral head

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.

Summary

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

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.

1

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

2

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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