STELKAST BIPOLAR SYSTEM

• K Number: K972961
• Device Name: STELKAST BIPOLAR SYSTEM
• Manufacturer: STELKAST COMPANY
• Date Cleared: 1997-11-04 ( 85 days)
• Product Code: JDI KWY
• Regulation Number: 888.3350

Intended Use

- 1. Fractures of the proximal femur - 2. Non-unions of proximal femoral neck fractures. - Aseptic necrosis of the femoral head: 3. - 4. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum. - 5. Salvage of failed total hip arthroplasty.

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary focuses on the intended use and anatomical site of a hip implant device and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.

Therapeutic

Yes
The "Intended Use / Indications for Use" section lists several medical conditions (e.g., fractures, non-unions, aseptic necrosis, arthritis) for which the device is intended, indicating its use in treating or managing health conditions.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" section describes conditions that the device is used to treat or manage (e.g., fractures, non-unions, aseptic necrosis, arthritis, failed arthroplasty), rather than to diagnose. There is no mention of the device identifying or characterizing a medical condition.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The intended uses relate to orthopedic procedures, which typically involve hardware implants or surgical tools, making it unlikely to be software-only, but without a description, it's impossible to confirm.

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 treatment of bone and joint conditions in the human body (fractures, non-unions, necrosis, arthritis, failed arthroplasty). These are clinical indications for a medical device used in vivo (within the body) or for surgical procedures.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
• Anatomical Site: The anatomical sites mentioned (proximal femur, femoral head, hip, acetabulum) are all parts of the human musculoskeletal system, consistent with a device used for orthopedic procedures.

IVDs are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device's intended use and anatomical sites clearly indicate it is a medical device used for treatment or repair within the body, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• 1. Fractures of the proximal femur
• 2. Non-unions of proximal femoral neck fractures.
• Aseptic necrosis of the femoral head: 3.
• 4. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
• 5. Salvage of failed total hip arthroplasty.

Product codes

KWY, JDI

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

proximal femur, femoral neck, femoral head, hip

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

Not Found

Key Metrics

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

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.

Summary

0

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 1997

Mr. Donald A. Stevens President Skelkast, Inc. 800 Vinal Street, Suite B-210 Pittsburgh, Pennsylvania 15212

K972961 Re: Skelkast Bipolar System Regulatory Class: II Product Codes: KWY and JDI Dated: August 8, 1997 Received: August 11, 1997

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 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 Requlation (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.

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Page 2 - Mr. Donald A. Stevens

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
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): K972961

Device Name: StelKast Bipolar System

Indications For Use:

• 1. Fractures of the proximal femur
• 2. Non-unions of proximal femoral neck fractures.
• Aseptic necrosis of the femoral head: 3.
• 4. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
• 5. Salvage of failed total hip arthroplasty.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K97296/

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

(Optional Format 1-2-96)