BIOMET PHOENIX ANKLE NAIL SYSTEM

• K Number: K081243
• Device Name: BIOMET PHOENIX ANKLE NAIL SYSTEM
• Manufacturer: BIOMET TRAUMA
• Date Cleared: 2008-06-27 ( 57 days)
• Product Code: HSB
• Regulation Number: 888.3020
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K070955 , K063570 , K021786 , K991790
• Predicate For: K102577 , K121575 , K123810

Intended Use

The Biomet Phoenix™ Ankle Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

1. Avascular necrosis of the talus
2. Failed total ankle arthroplasty
3. Trauma (malunited tibial pilon fracture)
4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
5. Revision ankle arthrodesis
6. Neuroarthropathy
7. Rheumatoid arthritis
8. Osteoarthritis
9. Pseudoarthrosis

Device Description

The Biomet Phoenix™ Nail System is an intramedullary nail system comprised of Ti-6Al-4V and UHMWPE.

AI/ML Overview

This document describes the Biomet Phoenix™ Ankle Nail System, an intramedullary nail system for tibiotalocalcaneal arthrodesis (ankle fusion). The 510(k) summary indicates that the device's substantial equivalence was established through non-clinical testing.

Here's an analysis of the provided information, focusing on acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance (Non-Clinical Testing): The device should be functional within its intended use.	Engineering analyses comparing the Biomet Phoenix™ Ankle Nail System to a predicate device were conducted. The results indicated that the Biomet Phoenix™ Ankle Nail System was functional within its intended use.
Technological Characteristics: The materials, design, and sizing of the device should be similar or identical to predicate devices.	The technological characteristics (materials, design, sizing) of the Biomet Phoenix™ Ankle Nail System are similar or identical to the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: Not applicable. The primary evidence for substantial equivalence came from engineering analyses and comparisons to predicate devices, not studies with a "test set" of patient data.
• Data Provenance: Not applicable for patient data. The non-clinical testing involved engineering analyses.

3. 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 establishment was conducted. The evaluation was based on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• Not applicable. This device is a medical implant (intramedullary nail), not an AI algorithm or diagnostic tool. Its performance is related to its mechanical properties and design, not an algorithm's output.

7. Type of Ground Truth Used:

• Engineering Principles and Predicate Device Characteristics: The "ground truth" for demonstrating the device's functionality and substantial equivalence was based on established engineering principles applied during the non-clinical tests and direct comparison of the device's characteristics (materials, design, sizing) to those of legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not applicable. There was no training set in the context of an AI/ML algorithm. The evaluation was based on non-clinical testing and comparison to predicate devices.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. There was no training set. The "ground truth" for the non-clinical testing would have been derived from established biomechanical testing standards and expected performance based on the predicate devices.

Summary

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K081243 pg 1 of 2

510(k) Summary Biomet Phoenix™ Ankle Nail System

Preparation Date:	June 25, 2008
Applicant/Sponsor:	Biomet Trauma (aka EBI; names may be used interchangeably)100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Debra L. Bing
Proprietary Name:	Biomet Phoenix™ Ankle Nail System
Common Name:	Intramedullary fixation rod
Classification Name:	Rod, Fixation, Intramedullary and Accessories (21 CFR 888.3020)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Acid Etched Lag Screws	K070955	Biomet Trauma
Tibial Locking Nail System	K063570	Biomet Trauma
Ankle Arthrodesis Nail	K021786	Biomet, Inc.
UltiMax Ankle Fusion Rod	K991790	Encore Orthopedics, Inc

Device Description:

The Biomet Phoenix™ Nail System is an intramedullary nail system comprised of Ti-6Al-4V and UHMWPE.

Indications for Use:

The Biomet Phoenix™ Ankle Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

• 1. Avascular necrosis of the talus
• 2. Failed total ankle arthroplasty
• 3. Trauma (malunited tibial pilon fracture)
• 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• 5. Revision ankle arthrodesis
• 6. Neuroarthropathy
• 7. Rheumatoid arthritis
• 8. Osteoarthritis
• 9. Pseudoarthrosis

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KOS1243 pg a.f2

Summary of Technologies:

The technological characteristics (materials, design, sizing) of the Biomet Phoenix™ Nail System are similar or identical to the predicate devices.

Non-Clinical Testing: Engineering analyses comparing the Biomet Phoenix™ Nail System to a predicate device were conducted to determine substantial equivalence. The results indicated that the Biomet Phoenix™ Nail System was functional within its intended use.

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

All trademarks are property of Biomet, Inc.

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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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2008

Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K081243

Trade/Device Name: Biomet Phoenix Ankle Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 29, 2008 Received: May 1, 2008

Dear Ms. Alexander:

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 (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. Susan Alexander

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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Mark N. Milkeron

Mark N. Melkerson 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):_K0812 43

Device Name: _______________________________________________________________

The Biomet Phoenix™ Ankle Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

• 1. Avascular necrosis of the talus
• 2. Failed total ankle arthroplasty
• 3. Trauma (malunited tibial pilon fracture)
• 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• 5. Revision ankle arthrodesis
• 6. Neuroarthropathy
• 7. Rheumatoid arthritis
• 8. Osteoarthritis
• 9. Pseudoarthrosis

Prescription Use __ AES (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)

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

510(k) Number

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.