REGENERX RINGLOC + MODULAR ACETABULAR SHELLS by BIOMET, INC.

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed.

The Indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

Device Description

All devices are metallic, hemispherical, modular acetabular shell components. All shells have Regenerex™ (porous Ti-6Al-4V) applied to the exterior fixation surface. Each shell utilizes a modular polyethylene liner and a modular femoral head component that is a taper fit onto a femoral stem intra-operatively.

AI/ML Overview

This Biomet Regenerex™ RingLoc® + Modular Acetabular Shell 510(k) submission (K070369) is for a hip replacement component. This type of device relies on substantial equivalence to a predicate device rather than performance against specific analytical or clinical acceptance criteria in the same way an AI/ML device would.

Therefore, many of the requested categories are not applicable to this type of submission. However, I can still extract relevant information, and indicate "Not Applicable" where appropriate.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not applicable for this device type)	Reported Device Performance
Substantial Equivalence to a predicate device.	The device is geometrically similar or identical to the predicate device (Porous Coated Acetabular Components, 510(k) K050124). Non-clinical testing (design verification bench tests and validation activities) was performed, and the results did not raise new issues of safety and effectiveness.
	Intended Use: Cemented or non-cemented total hip 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 procedures where other treatment or devices have failed.
	Indications for Constrained Liners: General use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

2. Sample size used for the test set and the data provenance

Test set sample size: Not Applicable. This submission relies on substantial equivalence to a predicate device and non-clinical bench testing, not a traditional "test set" of patient data for performance evaluation in the context of AI/ML or diagnostic devices.
Data provenance: Not Applicable. No patient data was used for performance testing described in this submission. The "data" refers to the results of bench tests on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No patient-specific ground truth was established, as there was no clinical study involving patient data for performance evaluation.

4. Adjudication method for the test set

Not Applicable. No clinical test set requiring adjudication 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

Not Applicable. This is a medical device for hip replacement, not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this type of submission is primarily established through engineering principles, material science, and consistency with the performance characteristics of an already legally marketed predicate device. The non-clinical bench testing aims to demonstrate that the new device performs as expected according to established standards for mechanical and material properties relevant to hip implants, similar to the predicate.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an AI/ML model for this medical device submission.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or corresponding ground truth for this device.

Summary

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K070369
BIOMET

510(k) Summary

Preparation Date: March 7, 2007

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Robert Friddle, Requlatory Affairs Specialist

Proprietary Name: Regenerex™ RingLoc® + Modular Acetabular Shell

Common Name: Acetabular component for a total hip replacement

Classification Code(s)/Name(s): Class II

Product Classification Codes, Names and Regulation numbers:

1. JDG, prosthesis, hip, femoral component, cemented, metal 21 CFR 888.3360
1. JDI, prosthesis, hip, semi-constrained, metal/polymer, cemented 21 CFR 888.3350
1. KWZ, prosthesis, hip, constrained, cemented or uncemented, metal/polymer 21 CFR 888.3310
1. LPH, prosthesis, hip, semi-constralned, metal/polymer, porous Uncemented 21 CFR 888.3358
1. LWJ, prosthesis, hip, semi-constrained, metal/polymer, Uncemented 21 CFR 888.3360
1. LZO, prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, Uncemented 21 CFR 888.3353
1. MAY, prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous cemented, osteophilic finish 21 CFR 888.3353
1. MBL, prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous 21 CFR 888.3358
1. MEH, prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate 21 CFR 888.3353

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Porous Coated Acetabular Components, 510(k) K050124, deared October 4, 2005

Device Description: All devices are metallic, hemispherical, modular acetabular shell components. All shells have Regenerex™ (porous Ti-6Al-4V) applied to the exterior fixation surface. Each shell utilizes a modular polyethylene liner and a modular femoral head component that is a taper fit onto a femoral stem intra-operatively.

Image /page/0/Figure/20 description: The image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46682. The office number is 574.267.66.39, the fax number is 574.267.8137, and the email address is biomet@biomet.com.

9 - Page 1 of 2

MAR 0 9 2007

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K070369

Biomet Manufacturing Corp. Regenerex Modular Acetabular Shell Page 2 of 2

Intended Use: Cemented or non-cemented total hip replacement in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Correction of functional deformity
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
1. Revision procedures where other treatment or devices have falled.

The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, foint or soft tissue laxity, neuromuscular disease, or intra-operative instablify and for whom all other options to constrained acetabular components have been considered.

Summary of Technologies: The devices covered by this 510(k) are geometrically similar or identical to the predicate.

Non-Clinical Testing: Device speditc risk analysis resulted in performance of design verification bench tests and validation activities. The results of design verification and validation activities do not raise new issues of safety and effectiveness.

Clinical Testing: None provided.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 9 2007

Biomet Manufacturing Corp. c/o Mr. Robert Friddle Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K070369

Trade/Device Name: Regenerex™ RingLoc® + Modular Acetabular Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI, JDG, KWZ, LWJ, LZO, MAY, MBL, MEH Dated: January 29, 2007 Received: February 8, 2007

Dear Mr. Friddle:

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 - Mr. Robert Friddle

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millerson

Mark N. Melkerson Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K070369

510(k) Number (if known):

Device Name: Regenerex™ RingLoc® + Modular Acetabular Shell

Indications For Use: Cemented or non-cemented total hip replacement in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Correction of functional deformity
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
1. Revision procedures where other treatment or devices have failed.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Millman

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

510(k) Number K070369

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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.