GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS

• K Number: K031734
• Device Name: GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2003-07-01 ( 27 days)
• Product Code: JDI
• Regulation Number: 888.3350

Intended Use

The indications for use of the "Generation 4" Polished Femoral Hip Prosthesis include: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid Arthritis. 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision procedures where other treatments or devices have failed. The "Generation 4" Polished Femoral Hip Prosthesis is intended for total hip arthroplasty, and is intended for cemented use only.

Device Description

The Generation 4 Polished Femoral Hip Prosthesis is a series of implants meant to replace the patient's natural hip femoral neck and head due to disease or accident. The material is forged Co-Cr-Mo per ASTM F 799. They are designed for use with bone cement. General implant surfaces are highly polished and proximal and distal cement centralizers are offered for optimum stem placement within the canal. Stability within the cement mantle is enhanced by both a 4 mm medial collar designed to rest upon the calcar, and the bi-planer stem geometry which creates a wedge within the canal. Implant sizing is graduated for different patient anatomies. Stem geometry is undersized to stated stem and instrument sizing so as to include a cement mantle. A trapezoidal neck design is offered on all sizes for increased range of motion. These devices accept a modular head used with associated acetabular reconstructive shells and liners. Contraindications are similar to comparable devices designed for replacement of the patient's natural hip femoral neck due to arthritic diseases or accident.

Predicate Devices

K023085

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical hip prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is a hip prosthesis, which is a medical implant designed to treat various joint diseases and injuries, thereby restoring function and alleviating symptoms. This aligns with the definition of a therapeutic device.

Diagnostic

No

The device is a hip prosthesis, which is an implant used to replace a damaged hip joint, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a series of implants made of forged Co-Cr-Mo, designed to replace the patient's natural hip femoral neck and head. This is a physical medical device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Description: The "Generation 4" Polished Femoral Hip Prosthesis is an implant designed to replace a part of the patient's hip joint. It is a physical device implanted into the body.
• Intended Use: The intended use is to treat conditions affecting the hip joint through surgical replacement, not to analyze biological samples.

The information provided clearly describes a surgical implant, not a device used for testing biological samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The indications for use of the Generation 4 Polished Femoral Hip Prosthesis include:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid Arthritis.
• 3. Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4. the proximal femur with head involvement, unmanageable using other techniques.
• 5. Revision procedures where other treatments or devices have failed.

The Generation 4 Polished Femoral Hip Prosthesis is intended for use in total hip arthroplasty, and is intended for cemented use only.

Product codes

JDI

Device Description

The Generation 4 Polished Femoral Hip Prosthesis is a series of implants meant to replace the patient's natural hip femoral neck and head due to disease or accident. The material is forged Co-Cr-Mo per ASTM F 799. They are designed for use with bone cement. General implant surfaces are highly polished and proximal and distal cement centralizers are offered for optimum stem placement within the canal. Stability within the cement mantle is enhanced by both a 4 mm medial collar designed to rest upon the calcar, and the bi-planer stem geometry which creates a wedge within the canal.

Implant sizing is graduated for different patient anatomies. Stem geometry is undersized to stated stem and instrument sizing so as to include a cement mantle. A trapezoidal neck design is offered on all sizes for increased range of motion. These devices accept a modular head used with associated acetabular reconstructive shells and liners. Contraindications are similar to comparable devices designed for replacement of the patient's natural hip femoral neck due to arthritic diseases or accident.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Femoral neck, hip, proximal femur

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

Non-Clinical Testing: All 10 tested stems passed available ISO / ASTM as well as in house parameters.

Clinical Testing: No clinical testing was necessary for determination of substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K023085

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

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Image /page/0/Picture/1 description: The image shows the text "K031734" at the top, followed by "JUL 1 2003" in the middle. Below that is the logo for "BIOMET" in a stylized font. The text "ORTHOPEDICS, INC" is at the bottom of the image.

Summary of Safety and Effectiveness

Applicant/Sponsor: Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

• Gary Baker Contact Person: 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Telephone: [phone] Fax: [phone]
  Proprietary Name: "Generation 4" Polished Femoral Hip Prosthesis

Common Name: Femoral Component for Cemented Use

Classification Name(s): Prosthesis, Hip, Semi-Constrained, Cemented, Metal/Polymer (888.3350)

Product Code(s): JDI

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

RX-90 Cemented Hip Prosthesis - Biomet Inc.(K023085).

Device Description: The Generation 4 Polished Femoral Hip Prosthesis is a series of implants meant to replace the patient's natural hip femoral neck and head due to disease or accident. The material is forged Co-Cr-Mo per ASTM F 799. They are designed for use with bone cement. General implant surfaces are highly polished and proximal and distal cement centralizers are offered for optimum stem placement within the canal. Stability within the cement mantle is enhanced by both a 4 mm medial collar designed to rest upon the calcar, and the bi-planer stem geometry which creates a wedge within the canal.

Implant sizing is graduated for different patient anatomies. Stem geometry is undersized to stated stem and instrument sizing so as to include a cement mantle. A trapezoidal neck design is offered on all sizes for increased range of motion. These devices accept a modular head used with associated acetabular reconstructive shells and liners. Contraindications are similar to comparable devices designed for replacement of the patient's natural hip femoral neck due to arthritic diseases or accident.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive . 56 E. Ben Drive Warsaw, IN 46582

()FFICE 574.267.6639

FAX [phone]

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E-MAIL [e-mail]

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Indications for Use: The indications for use of the Generation 4 Polished Femoral Hip Prosthesis include:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid Arthritis.
• 3. Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4. the proximal femur with head involvement, unmanageable using other techniques.
• 5. Revision procedures where other treatments or devices have failed.

The Generation 4 Polished Femoral Hip Prosthesis is intended for use in total hip arthroplasty, and is intended for cemented use only.

• Summary of Technologies: The "Generation 4" Femoral Hip Prosthesis is manufactured from the same materials, utilizing the same manufacturing practices, and conforming to the same standards as other femoral hip prostheses cleared for cemented use.
• Non-Clinical Testing: All 10 tested stems passed available ISO / ASTM as well as in house parameters.

Clinical Testing: No clinical testing was necessary for determination of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a bird. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2003

Mr. Gary Baker Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K031734

Trade/Device Name: "Generation 4" Polished Femoral Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: June 3, 2003 Received: June 4, 2003

Dear Mr. Baker:

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 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. Gary Baker

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.

Sincere, yours,

Mark N. Millman

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): K031734

Device Name: "Generation 4" Polished Femoral Hip Prosthesis

Indications for Use: The indications for use of the "Generation 4" Polished Fernoral Hip Prosthesis include:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid Arthritis.
• 3. Correction of functional deformity
• 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
• 5. Revision procedures where other treatments or devices have failed.

The "Generation 4" Polished Femoral Hip Prosthesis is intended for total hip arthroplasty, and is intended for cemented use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	OR	Over-the-Counter Use (Optional Format 1-2-96)
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(Division Sign-Off)
Division of General, Restorative and Neurological Devices

510(k) Number	K031734
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