EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE by BIOMET, INC.

Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
a) Joint destruction and/or subluxation visible on x-ray
b) Resistance to conservative treatment
Primary replacement after fracture of the radial head
Symptomatic sequelae after radial head resection
Revision following failed radial head arthroplasty
The device is intended for single use with or without bone cement.

Device Description

The ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a stem and a head. The tapered stem is cemented into the intramedullary canal of the radius. The enlarged head has a highly polished concave surface to articulate with the natural bone of the humerus. The proximal portion of the sterns are roughened by a titanium Bond Coat coating. The components connect via a dove-tail joint secured by a locking screw. The device is available in four head diameters, 18mm, 20mm, 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

AI/ML Overview

This looks like a 510(k) premarket notification document for a medical device. Based on the provided text, the device is the ExploR™ Modular Radial Head Replacement Device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Composition	Two-piece cobalt alloy
Design Characteristics	Stem and head (tapered stem, enlarged polished concave head)
Sizing	Four head diameters (18, 20, 22mm); varying head heights (8-20mm); six stem diameters with varying lengths
Intended Use	Replacement of radial head for: 1) Degenerative/post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction/subluxation on X-ray, resistance to conservative treatment) 2) Primary replacement after radial head fracture 3) Symptomatic sequelae after radial head resection 4) Revision following failed radial head arthroplasty
Safety and Effectiveness	Demonstrated through substantial equivalence to predicate devices (K040611, K984290, K002644, K991915) based on technological characteristics (materials, design, sizing, indications) and non-clinical testing.
Biocompatibility	Implied to be acceptable as it uses materials similar to legally marketed predicate devices.
Mechanical Integrity	Engineering analysis and mechanical testing were provided.

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "Clinical Testing: None provided as a basis of substantial equivalence."

This indicates that clinical studies were not performed to demonstrate the device meets acceptance criteria in the traditional sense of a clinical trial proving safety and efficacy. Instead, the basis for market clearance (substantial equivalence) relies on non-clinical data and comparison to predicate devices.

Given the lack of clinical testing, the following information points related to clinical studies (test sets, ground truth, expert involvement, MRMC, standalone performance, training sets) are not applicable in this case.

Therefore, for the specific questions you asked about a study proving the device meets acceptance criteria:

A table of acceptance criteria and the reported device performance: (Provided above) The acceptance criteria are largely implied by the description and intended use of the device, and its similarity to predicate devices. The reported performance refers to its physical characteristics and functionality as designed.
Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used for substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed for substantial equivalence.
Adjudication method for the test set: Not applicable.
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 device is a physical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. No machine learning training set was used.
How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) submission successfully achieved market clearance based on non-clinical testing (engineering analysis and mechanical testing) and the demonstration of substantial equivalence to existing, legally marketed predicate devices. "Substantial equivalence" here means that the new device has the same intended use and technological characteristics as the predicate devices, or if there are differences, those differences do not raise new questions of safety or effectiveness. No clinical studies were required or provided.

Summary

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AUG 5 - 2005

K051385 P 1/1

Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics Inc. The word "BIOMET" is in large, bold, sans-serif font, with each letter enclosed in a rectangular box except for the "O", which is a circle. Below "BIOMET" is the text "ORTHOPEDICS INC." in a smaller, thinner font.

510(k) Summar

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

Contact Person: Patricia Sandborn Beres Telephone: (574) 267-6639

Proprietary Name: ExploR™ Modular Radial Head Replacement Device

Common Name: Elbow hemi-prosthesis

Classification Name: Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)

Leqally Marketed Devices to Which Substantial Equivalence Is Claimed: Modular Radial Head Replacement Device (K040611), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Evolve Modular Radial Head (Wright Medical Tech. Inc., K991915)

Device Description: The ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a stem and a head. The tapered stem is cemented into the intramedullary canal of the radius. The enlarged head has a highly polished concave surface to articulate with the natural bone of the humerus. The proximal portion of the sterns are roughened by a titanium Bond Coat coating. The components connect via a dove-tail joint secured by a locking screw. The device is available in four head diameters, 18mm, 20mm, 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

Intended Use: The ExploR™ Modular Radial Head Replacement Device is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- Joint destruction and/or subluxation visible on x-ray a)
- b) Resistance to conservative treatment
1. Primary replacement after fracture of the radial head
1. Symptomatic sequelae after radial head resection
1. Revision following failed radial head arthroplasty

The device is intended for single use with or without bone cement.

Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Modular Radial Head Replacement Device are similar to the predicate devices.

Non-Clinical Testing: Engineering analysis and mechanical testing were provided.

Clinical Testing: None provided as a basis of substantial equivalence.

MAILING ADDRESS PO. Box 58" Warsaw, IN 46581 0588

SHIPPING ADDRESS s(s E. Bell Drive Warsaw, IN 16582

OFFICE 574.26 ' (66.30)

Image /page/0/Picture/25 description: The image contains the word "FAX" at the top. Below that is a series of numbers, "574.26 7 81 37". There is also a time stamp of "1:18" in the upper left corner.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

AUG 5 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K051385

Trade/Device Name: ExploR™ Modular Radial Head Replacement Device Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: May 25, 2005 Received: May 27, 2005

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 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. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 510(k) rms retet natification. The FDA finding of substantial equivalence of your device to a legally premated 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Atyl Rlwrla

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

Enclosure

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Indications for Use

510(k) Number (if known):

K051385

ExploR™ Modular Radial Head Replacement Device ---Device Name:

Indications For Use: The ExploR™ Modular Radial Head Replacement Device is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a) Joint destruction and/or subluxation visible on x-ray
- b) Resistance to conservative treatment
1. Primary replacement after fracture of the radial head
1. Symptomatic sequelae after radial head resection
1. Revision following failed radial head arthroplasty

The device is intended for single use with or without bone cement.

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

Over-The-Counter Use (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)

Stpt Rhodes

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(Division' Division of General, Restorative and Neurological Devices

510(k) Number K051385

Regulation Number and Section

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.