BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL

K091976 · Biomet Trauma · HSB · Aug 17, 2009 · Orthopedic

Device Facts

• Record ID: K091976
• Device Name: BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
• Applicant: Biomet Trauma
• Product Code: HSB · Orthopedic
• Decision Date: Aug 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 10. Post-traumatic arthrosis 11. Previously infected arthrosis 12. Charcot foot 13. Severe endstage degenerative arthritis 14. Severe defects after tumor resection 15. Pantalar arthrodesis

Device Story

Intramedullary nail system (nails and screws) for tibiotalocalcaneal arthrodesis. Used by orthopedic surgeons in clinical settings to stabilize the ankle joint. Device provides mechanical fixation to facilitate bone fusion in patients with severe ankle pathology or deformity. Benefits include structural support for complex reconstructive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary nail system consisting of nails and screws. Materials: Ti-6Al-4V alloy and UHMWPE. Regulatory class II, product code HSB (Intramedullary fixation rod).

Indications for Use

Indicated for patients requiring tibiotalocalcaneal arthrodesis due to conditions including avascular necrosis of the talus, failed total ankle arthroplasty, trauma, severe deformity/instability (e.g., talipes equinovarus, neuromuscular disease), revision arthrodesis, neuroarthropathy, arthritis (rheumatoid, osteoarthritis, post-traumatic, endstage), pseudoarthrosis, Charcot foot, or tumor resection defects. Contraindicated in patients with dysvascular limb, severe longitudinal deformity, insufficient plantar heel pad, or cases where isolated ankle/subtalar fusion is sufficient.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 .: [phone], ext. 2260 Fax: [phone] E-mail: [e-mail]

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:

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.

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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 [phone] or [phone] 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
- 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
- 10. Post-traumatic arthrosis
- 11. Previously infected arthrosis
- 12. Charcot foot
- 13. Severe endstage degenerative arthritis
- 14. Severe defects after tumor resection
- 15. 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