The indications for the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are for ) 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; and 5) Revision procedures where other treatments or devices have failed.

Device Description

The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are the same as their predicate, except for a modified profile on two of the sizes and the addition of Hydroxyapatite Coating.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a hip implant. It primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria.

Therefore, many of the requested fields regarding acceptance criteria, study design, and performance metrics are not applicable or not provided in this type of regulatory submission. This document aims to show the new device is as safe and effective as an already legally marketed device, and typically relies on non-clinical testing for equivalence.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance Study Information

Information Category	Details from Document
1. Table of Acceptance Criteria and Reported Device Performance	Not Applicable/Not Provided. The document states: "Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems presented no new risks and were, therefore, substantially equivalent to the predicate device." This indicates that the acceptance criteria revolved around demonstrating mechanical equivalence and no new risks compared to the predicate device (Modular Reach™ Hip- 510(k) K994038), rather than performance against pre-defined clinical or analytical thresholds. Specific numerical performance metrics for the device are not reported in this summary. The "performance" is implicitly deemed equivalent to the predicate.
2. Sample size used for the test set and data provenance	Not Applicable. No clinical test set was used. Mechanical testing was performed, but details on the sample size for that testing are not provided in this summary. The data provenance is "Non-Clinical Testing" which suggests laboratory testing rather than data from human subjects.
3. Number of experts used to establish ground truth for test set and qualifications	Not Applicable. No clinical test set with ground truth established by experts was used. The substantial equivalence was based on mechanical testing and engineering justification.
4. Adjudication method for the test set	Not Applicable. No clinical test set requiring adjudication was used.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information	Not Applicable. This is a medical device (hip implant) 510(k) submission, not an AI/imaging diagnostic device. Therefore, no MRMC study, human reader improvement statistics, or AI assistance calculations are relevant or provided.
6. Standalone (algorithm only without human-in-the-loop performance) study information	Not Applicable. This is a physical medical device (hip implant) and not an algorithm or AI system. Its function is not "standalone" in the computational sense.
7. Type of ground truth used	Not Applicable. In the context of this 510(k), "ground truth" was established through "Mechanical Testing with an Engineering Justification" to demonstrate that the device "presented no new risks and were, therefore, substantially equivalent to the predicate device." It's based on engineering principles and comparison to the predicate's established performance, rather than clinical outcomes or pathology data for this specific device.
8. Sample size for the training set	Not Applicable. No training set, in the sense of machine learning, was used. The development and testing were based on mechanical engineering principles.
9. How ground truth for the training set was established	Not Applicable. As no training set was used, no ground truth needed to be established for it. The device design and testing are based on established biomechanical and materials science principles, and comparison to the predicate device's design and previous testing results (implicitly the "ground truth" for what constitutes a safe and effective hip implant of this type).

Summary

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AUG 1 6 2002

K012463 pge 172

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587
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Contact Person: Dalene T. Binkley Telephone: (574) 267-6639

Proprietary Name: HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems

Common Name: Prosthetic Hip Joint - Hydroxyapatite (HA) Coated Porous Femoral Stem

Classification: hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Device Classification: Class II

Legally Marketed Device to which Substantial Equivalence is Claimed: Modular Reach™ Hip- 510(k) K994038.

Device Description: The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are the same as their predicate, except for a modified profile on two of the sizes and the addition of Hydroxyapatite Coating.

Indications for Use: The indications for the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are for ) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

Summary of Technologies: The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems- the materials, design, sizing, and indications are similar or identical to the predicate devices.

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

트

000046

()FFICE 574.267.6639 ■ ■ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

E-MAIL biomet@biome1.com

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Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems presented no new risks and were, therefore, substantially equivalent to the predicate device.

Clinical Testing: No clinical testing was provided as a basis for 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 graphic of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2002

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc. P.O. box 587 Warsaw, Indiana 46581-0587

Re: K022463

Trade/Device Name: HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems 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 Dated: July 15, 2002 Received: July 26, 2002

Dear Ms. Binkley:

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 - Ms. Dalene T. Binkley

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark A. 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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Page / of /

510 (k) NUMBER (IF KNOWN): __ K o 2 >46 -

DEVICE NAME: HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems

INDICATIONS FOR USE:

(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

Over-The-Counter-Use No
(Optional Format 1-2-96)

Mark H. Millican

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

510(k) Number K022463

0000008

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.