EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE

K051385 · Biomet, Inc. · KWI · Aug 5, 2005 · Orthopedic

Device Facts

• Record ID: K051385
• Device Name: EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
• Applicant: Biomet, Inc.
• Product Code: KWI · Orthopedic
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

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 2) Primary replacement after fracture of the radial head 3) Symptomatic sequelae after radial head resection 4) Revision following failed radial head arthroplasty The device is intended for single use with or without bone cement.

Device Story

ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy elbow hemi-prosthesis; consists of stem and head components. Stem is cemented into intramedullary canal of radius; head articulates with natural humerus bone. Components connect via dove-tail joint secured by locking screw. Proximal stem portion features titanium Bond Coat. Available in multiple head diameters (18-22mm) and heights (8-20mm). Used by orthopedic surgeons in clinical settings to restore joint function, reduce pain, and address post-traumatic or degenerative radial head conditions. Benefits include improved joint motion and stability following fracture or failed arthroplasty.

Clinical Evidence

No clinical data provided as a basis of substantial equivalence. Evidence consists of engineering analysis and mechanical testing.

Technological Characteristics

Materials: Cobalt alloy prosthesis with titanium Bond Coat. Design: Two-piece modular system (stem and head) connected via dove-tail joint and locking screw. Dimensions: Four head diameters (18-22mm), head heights 8-20mm, six stem diameters. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion) with joint destruction/subluxation and resistance to conservative treatment; primary replacement after radial head fracture; symptomatic sequelae post-resection; or revision of failed radial head arthroplasty.

Regulatory Classification

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.

Predicate Devices

• Modular Radial Head Replacement Device (K040611)
• Radial Head Surface Replacement (Implex Corp. K984290)
• Radial Head Implant (Avanta Orthop., Inc., K002644)
• Evolve Modular Radial Head (Wright Medical Tech. Inc., K991915)

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone]

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
- 2) Primary replacement after fracture of the radial head
- 3) Symptomatic sequelae after radial head resection
- 4) 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

1

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.

E MILI Dicoraret («+ ! bic) ! ! ! ! ! . ! . ! . ! . !

{1}------------------------------------------------

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.

{2}------------------------------------------------

## 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 [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/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

{3}------------------------------------------------

## 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
- 2) Primary replacement after fracture of the radial head
- 3) Symptomatic sequelae after radial head resection
- 4) 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

Page 1 of 1

(Division' Division of General, Restorative and Neurological Devices

510(k) Number K051385