OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM by OSTEOMED L.P.

The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful MTP joint.

The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.

The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

Device Description

The OsteoMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head. Primary fixation is intended to be used with bone cement or press fit without bone cement.

AI/ML Overview

The provided text is a 510(k) summary for the OsteoMed Metatarsal Resurfacing Implant System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not found in this type of submission. This 510(k) summary does not describe a clinical study with performance endpoints, ground truth, or expert review for a medical imaging or AI device.

Here's an breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The 510(k) summary for this device does not present specific performance acceptance criteria or report performance metrics in the way a study for a diagnostic or AI device would. The core of this submission is to demonstrate equivalence based on:

Intended use
Materials
Design
Operational principle

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

Not applicable. There is no "test set" in the context of a clinical performance study described for this implant.

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

Not applicable. There is no ground truth establishment for a test set described.

4. Adjudication method for the test set

Not applicable.

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 not an AI or diagnostic imaging device.

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

Not applicable. This is not an AI or diagnostic imaging device.

7. The type of ground truth used

Not applicable. No ground truth is described.

8. The sample size for the training set

Not applicable. There is no "training set" for an algorithm described.

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

Not applicable.

Summary of the Acceptance Criteria and Study (as defined by this 510(k) submission):

The "acceptance criteria" for the OsteoMed Metatarsal Resurfacing Implant System, within the context of this 510(k) submission, are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices.

The "Study" that proves the device meets these "acceptance criteria":

The "study" or justification provided is a comparison to several predicate devices. The submission asserts that due to the "similarity in intended use, materials, design and operational principle to the predicate devices, OsteoMed believes that the OsteoMed Metatarsal Resurfacing Implant System does not raise any new safety or effectiveness issues."

Predicate Devices:

Arthrosurface CAP Great Toe Resurfacing Hemi- Arthroplasty Implant (K031859)
CAP Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370)
Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052)
OsteoMed 1st MPJ Hemi Implant System (K060536)
ReFlexion Great Toe System (K922211)
BioPro Hemi MPJoint (K041595)

Therefore, the "proof" is the argument for substantial equivalence based on these comparisons, rather than a clinical performance study with statistical endpoints specific to the device's function as an implant.

Summary

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

K07 3065

Image /page/0/Picture/1 description: The image shows the logo for OsteoMed. The logo is black and white and features the word "OsteoMed" in a bold, sans-serif font. The word is slightly curved and is surrounded by a black oval shape. The logo is simple and modern.

21 21 :

510(k) Summarv

Device Proprietary Name:	OsteoMed MetatarsalResurfacing Implant System
Device Common Name:	Metatarsal Resurfacing ImplantSystem
Classification Name:	KWD, Prosthesis, Toe, Hemi-,Phalangeal
Name of Submitter:	OsteoMed L. P.3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (972) 677-4601
Contact Person:	Piedad Peña

Contact Person:

Date Prepared:

February 8, 2008

Summary:

This submission describes the OsteoMed Metatarsal Resurfacing Implant System, a hemi arthroplasty implant system, for the metatarsophalangeal (MTP) joint for use in treatment of patients with degenerative and post-traumatic arthritis in the MTP joints in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux valgus, hallux rigidus, and an unstable or painfull MTP joint. OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

Equivalence for this device is based on similarities in intended use, materials, design and operational principle to the Arthrosurface CAP Great Toe Resurfacing Hemi- Arthroplasty Implant (K031859) and CAP Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370), Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052), OsteoMed 1st MPJ Hemi Implant System (K060536) and ReFlexion Great Toe System (K922211), and BioPro Hemi MPJoint (K041595).

OsteoMed L.P. 3885 Aranaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779

Colson A COLSON ASSOCIATE

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

073065

$\rho.^{2}/2$

Due to the similarity in intended use, materials, design and operational principle to the predicate devices, OsteoMed believes that the OsteoMed Metatarsal Resurfacing Implant System does not raise any new safety or effectiveness issues.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is composed of three curved lines that create the impression of feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2008

OsteoMed L.P. % Ms. Piedad Peña Regulatory Affairs Specialist 3885 Arapaho Road Addison, TX 75001

Re: K073065

Trade/Device Name: OsteoMed Metatarsal Resurfacing Implant System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: February 8, 2008 Received: February 11, 2008

Dear Ms. Peña:

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.

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

Page 2 - Ms. Piedad Peña

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulhausen

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

Enclosure

{4}------------------------------------------------

K073065

Indications for Use

510(k) Number (if known):

Device Name: OsteoMed Metatarsal Resurfacing Implant System

Indications for Use:

The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.

The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oubarebnem

Division of General, Restorative, Page 1 of 1 and Neurological Devices

(Posted November 13, 2003)

510(k) Number_ 1 0 7 300

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.