X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS

• K Number: K030501
• Device Name: X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2003-03-20 ( 29 days)
• Product Code: LPH
• Regulation Number: 888.3358
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K984296
• Predicate For: K042029

Intended Use

Non-cemented total joint replacement in cases of:

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 by other techniques.
5. Revision of previously failed total hip arthroplasty

Device Description

The X-Series Integral® femoral components are identical to the predicate Integral® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F-620. Additional stem diameters and lengths have been added to the product line. The insertion hole has been moved medially by 6mm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the X-Series Integral® Hip Femoral Components.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device design changes will not affect safety.	Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not affect the safety of the device.
Effectiveness: Similar to or identical to predicate device in technological characteristics (materials, design, sizing and indications).	Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Integral® femoral components are similar to or identical to the predicate device [Integral® Hip Femoral Component (K984296)].

Note: This submission primarily relies on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria based on novel performance targets. The "acceptance criteria" here are implicitly met by showing that the new device's changes (additional stem diameters and lengths, moved insertion hole) do not negatively impact safety or effectiveness when compared to the legally marketed predicate.

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

• Sample Size for Test Set: Not applicable. No clinical testing with human subjects or a dedicated test set for performance evaluation was conducted.
• Data Provenance: Not applicable. The testing was non-clinical (Finite Element Analysis and engineering analysis).

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

• Number of Experts: Not applicable. Ground truth was established through engineering analysis and Finite Element Analysis, not expert human review of a test set.
• Qualifications of Experts: Not specified, but would typically be biomedical engineers or similar professionals with expertise in biomechanics and materials science.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No human review test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• MRMC Study: No. This device is a hip implant, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This is a physical medical device (hip implant), not an algorithm. The "non-clinical testing" (Finite Element Analysis and engineering analysis) can be considered a form of standalone evaluation of the device's structural integrity and performance under simulated conditions.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is implicitly based on the established safety and effectiveness profile of the predicate device (Integral® Hip Femoral Component, K984296). For the design changes, the "ground truth" for the non-clinical tests would be the established principles of biomechanics, material science, and engineering standards (e.g., ASTM F-620 for titanium alloy). The analyses aimed to demonstrate that the changes did not deviate negatively from these established principles or the performance of the predicate.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. No machine learning training set was used. The "training" for this device's development comes from established engineering design principles and the manufacturing history of similar devices.

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

• How Ground Truth for Training Set Was Established: Not applicable. As there was no machine learning training set, there was no ground truth to establish for it in this context. The underlying knowledge base for the device design and non-clinical testing is derived from established engineering principles, material science, and regulatory standards for orthopedic implants.

Summary of the Study:

The study proving the device meets its "acceptance criteria" (which in this 510(k) context means proving substantial equivalence and non-inferiority regarding design changes) was entirely non-clinical.

• It consisted of Finite Element Analysis (FEA) and engineering analysis.
• These analyses aimed to insure the design changes would not affect the safety of the device, specifically the added stem diameters and lengths, and the 6mm medial repositioning of the insertion hole.
• The comparison was implicitly made against the established performance characteristics and safety profile of the predicate device, the Integral® Hip Femoral Component (K984296).
• No clinical testing (human trials) was provided or required for this 510(k) submission, as the changes were minor and substantial equivalence could be demonstrated non-clinically.

Summary

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K03050/ page 1 of 2

BIOMET

MAR 2 0 2003

Summary of Safety and Effectiveness

Applicant/Sponsor: Biomet Orthopedics, Inc.

Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist Phone: [phone]

Proprietary Name: X-Series Integral® Hip Femoral Components

Common Name: Hip replacement prosthesis

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (21 CFR 888.3558)

Legally Marketed Device to which Substantial Equivalence is Claimed: Integral® Hip Femoral Component (K984296)

Device Description: The X-Series Integral® femoral components are identical to the predicate Integral® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F-620. Additional stem diameters and lengths have been added to the product line. The insertion hole has been moved medially by 6mm.

Indications for Use: Non-cemented total joint replacement in cases of:

• 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 by other techniques.
• 5. Revision of previously failed total hip arthroplasty

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Integral® femoral components are similar to or identical to the predicate device.

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

SHIPPING ADDRESS SHEFRING ADDRE: Bell Drive: Warsaw, IN 46582

.

()FFICE 574.267.6639

FAX [phone]

E-MAIL [e-mail]

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page 2 of 2

Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device.

Clinical Testing: None provided

Integral is a trademark of Biomet, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581

Re: K030501

Trade/Device Name: X-Series Integral® Femoral Components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: February 14, 2003 Received: February 19, 2003

Dear Ms. Beres:

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

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Page 2 - Ms. Patricia Sandborn Beres

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. 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 may be obtained 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,

O Mark McMullen

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):

Device Name: X-Series Integral® Femoral Components

Indications For Use:

Non-cemented total joint replacement in cases of:

• 1. Noninflamatory 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 by other techniques.
• 5. Revision of previously failed total hip arthroplasty

Mach N. Melhern
Division Supt. of M

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030501

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use h 2 (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.