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
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K023085
• Predicate For: K052639

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.

AI/ML Overview

Acceptance Criteria and Study for "Generation 4" Polished Femoral Hip Prosthesis

This submission details the "Generation 4" Polished Femoral Hip Prosthesis, a femoral component for cemented use in total hip arthroplasty. The device is claimed to be substantially equivalent to the RX-90 Cemented Hip Prosthesis - Biomet Inc. (K023085).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Materials	Forged Co-Cr-Mo per ASTM F 799	Manufactured from the same materials as other cleared femoral hip prostheses.	Non-Clinical Testing
Manufacturing Practices	Same manufacturing practices as predicate devices.	Utilizes the same manufacturing practices as other cleared femoral hip prostheses.	Non-Clinical Testing
Standards Conformance	Conforms to relevant ISO/ASTM standards.	"All 10 tested stems passed available ISO / ASTM as well as in house parameters."	Non-Clinical Testing
Biomechanical Performance	(Implied) Mechanical stability and durability for intended use (e.g., stem placement, cement mantle enhancement, range of motion).	Bi-planer stem geometry for wedge stability, 4mm medial collar for calcar rest, trapezoidal neck for increased range of motion.	Device Description (design features supporting performance) & Non-Clinical Testing (conformance to standards addresses this indirectly)

Note: Specific quantitative acceptance criteria (e.g., minimum fatigue cycles, maximum wear rates) are not explicitly stated in the provided text for individual device performance metrics. Rather, the acceptance criteria are based on conformance to established standards and similarity to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 10 stems were tested.
• Data Provenance: The testing was "in house," implying that the data was generated within Biomet Orthopedics, Inc. The exact country of origin is not specified, but the applicant's address is Warsaw, Indiana, USA. The testing is non-clinical, meaning it's conducted in a laboratory setting, not on human subjects. This is a form of retrospective data in that it's performed on manufactured devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This device relied on non-clinical testing against ISO/ASTM standards and internal parameters. Therefore, no human experts were used to establish ground truth for a test set in the traditional sense of clinical opinion or diagnosis. The "ground truth" for non-clinical testing is compliance with established engineering and material standards and internal specifications, which would have been determined by engineers and material scientists. The document does not specify the number or qualifications of these internal experts.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1) is typically applied in clinical studies where expert consensus is needed to establish a "ground truth" for patient cases. Since this study involved non-clinical, laboratory testing against predetermined standards, no adjudication method was used. The results of the mechanical tests were objectively measured against the established ISO/ASTM and internal parameters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing: No clinical testing was necessary for determination of substantial equivalence." This type of study would involve human readers (e.g., surgeons evaluating X-rays or clinical outcomes) both with and without AI assistance, which is not relevant to this device's regulatory pathway.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was done. This is a medical device (hip prosthesis), not an AI algorithm. The performance evaluation was based on non-clinical, mechanical testing of the physical implant itself.

7. Type of Ground Truth Used

The ground truth used for the non-clinical testing was conformance to established ISO/ASTM standards and internal parameters for material properties and manufacturing. Specific examples mentioned are "ISO / ASTM" and "in house parameters."

8. Sample Size for the Training Set

No training set was used. This device is a physical implant, not an AI or machine learning model that requires a training set. The development of the device would have involved engineering design and testing, but not in the sense of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there was no training set for an AI algorithm (as this is a physical device), this question is not applicable. The "ground truth" for the device's design and manufacturing processes would be based on established engineering principles, material science, and prior knowledge from predicate devices and industry standards.

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

■

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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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.