Avascular necrosis of the talus
Failed total ankle arthroplasty
Trauma (malunited tibial pilon fracture)
Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
Revision ankle arthrodesis
Neuroarthropathy
Rheumatoid arthritis
Osteoarthritis
Pseudoarthrosis
Post-traumatic arthrosis
Previously infected arthrosis
Charcot foot
Severe endstage degenerative arthritis
Severe defects after tumor resection
Pantalar arthrodesis

Device Description

The Biomet Phoenix™ Ankle Nail System is an intramedullary nail system (nails and screws) comprised of Ti-6Al-4V and UHMWPE. The Biomet® Ankle Arthrodesis Nail System is an intramedullary nail system (nails and screws) comprised of T-6Al-4V.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (intramedullary fixation rod), not a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.

Here's what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

This document is a 510(k) submission, indicating a review by the FDA for substantial equivalence to a predicate device, not a clinical study with predefined acceptance criteria and performance reporting in the typical sense.
The letter states, "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...". This implies that the device met the regulatory acceptance criterion of being substantially equivalent to a predicate device.
No specific performance metrics are reported in this document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a clinical study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document refers to "input from surgeons who have reviewed the surgical technique" for contraindications, but this is not related to establishing ground truth for a test set in a clinical performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 document does not describe such a study and the device is an intramedullary fixation rod, not an AI diagnostic tool.

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

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary

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Image /page/0/Figure/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and connected to each other. Below the word "BIOMET" is the word "TRAUMA" in a smaller, sans-serif font. The word "TRAUMA" is also capitalized.

AUG 1 7 2009

K091976

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

Submitter:

Biomet Trauma 100 Interpace Parkway Parsippany, NJ 07054

2242816

Establishment Registration Number:

Contact:

Margaret F. Crowe Regulatory Affairs Project Manager Biomet Trauma 100 Interpace Parkway Parsippany, NJ 070654 Tel .: 973-299-9300, ext. 2260 Fax: 973-257-0232 E-mail: margaret.crowe@ebimed.com

Date Prepared:

August 12, 2009

Trade/Proprietary Name:

Biomet Phoenix™ Ankle Nail System Biomet® Ankle Arthrodesis Nail

Common/Usual Name: Intramedullary fixation rod

Classification Name: Rod, Fixation, Intramedullary and Accessories (21 CFR 888.3020)

Device Panel/Product Code: Orthopedics HSB

Device Description:

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K091976²/₂

Indications for Use:

The indications for use for both of these systems have been modified to include the following indications that are denoted with an asterisk(*):

Avascular necrosis of the talus �
Failed total ankle arthroplasty .
Trauma (malunited tibial pilon fracture) t
. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
Revision ankle arthrodesis .
Neuroarthropathy �
Rheumatoid arthritis .
Osteoarthritis ●
Pseudoarthrosis
Post-traumatic arthrosis*.
Previously infected arthrosis*
Charcot foot*
Severe endstage degenerative arthritis*
Severe defects after turnor resection*
Pantalar arthrodesis*

The following contraindications are being added to the product labeling. These labeling additions are being made based upon input from surgeons who have reviewed the surgical technique.

The additional contraindications are:

Dysvascular limb
Severe longitudinal deformity
Insufficient plantar heel pad
Situations where an isolated ankle or subtalar fusion can be performed

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 1 7 2009

Parsippany, New Jersey 07054

% Ms. Margaret F. Crowe 100 Interpace Parkway

Biomet Trauma

Re: K091976

Trade/Device Name: Biomet Phoenix Ankle Nail System and the Biomet Ankle Arthrodesis Nail

Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 29, 2009 Received: July 1, 2009

Dear Ms. Crowe:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Margaret F. Crowe

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbay Buelu

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Biomet Phoenix™ Ankle Nail System

Biomet® Ankle Arthrodesis Nail

The Biomet Phoenix™ Ankle Nail System and the Biomet® Ankle Arthrodesis Nail are indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

1. Avascular necrosis of the talus
1. Failed total ankle arthroplasty
1. Trauma (malunited tibial pilon fracture)
1. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
1. Revision ankle arthrodesis
1. Neuroarthropathy
1. Rheumatoid arthritis
1. Osteoarthritis
1. Pseudoarthrosis
1. Post-traumatic arthrosis
1. Previously infected arthrosis
1. Charcot foot
1. Severe endstage degenerative arthritis
1. Severe defects after tumor resection
1. Pantalar arthrodesis

Prescription Use X (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)

thunny of. Eym

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091976

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.