T2 ANKLE ARTHRODESIS NAIL

K051590 · Howmedica Osteonics Corp. · HSB · Jul 29, 2005 · Orthopedic

Device Facts

• Record ID: K051590
• Device Name: T2 ANKLE ARTHRODESIS NAIL
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Jul 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: . Post-traumatic or primary Arthrosis . . Previously infected arthrosis (second degree) . Revision of Failed Ankle Arthrodesis . . Failed Total Ankic Replacement . . Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) . . Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle . . Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot . . Ostheoartritis . . Nonunions or Pseudarthrosis of hindfoot and distal tibia . . Malunited tibial pilon fracture . . Charcot foot . t Severe endstage degenerative arthritis . Severe defects after tumor resection . . Pantalar arthrodesis

Device Story

T2® Ankle Arthrodesis Nail is an intramedullary fixation device for tibiotalocalcaneal fusion. Device is inserted via open or closed surgical technique; provides stabilization of hindfoot and ankle. Features locking mechanisms for static, dynamic, or compression modes. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical support to facilitate bone fusion in patients with severe ankle/hindfoot pathology. Single-use device.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Intramedullary fixation rod; metallic construction; designed for static, dynamic, or compression locking modes; single-use; intended for tibiotalocalcaneal arthrodesis.

Indications for Use

Indicated for patients requiring tibiotalocalcaneal arthrodesis and hindfoot/ankle stabilization due to conditions including post-traumatic/primary arthrosis, failed ankle arthrodesis or total ankle replacement, avascular necrosis of the talus, neuroarthropathy, neuromuscular deformity, rheumatoid arthritis, osteoarthritis, nonunions/pseudarthrosis, malunited tibial pilon fractures, Charcot foot, severe endstage degenerative arthritis, or severe defects post-tumor resection.

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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## JUL 2 9 2005

## K051590 510(k) Summary of Safety and Effectiveness: T2® Ankle Arthrodesis Nail

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | July 25, 2005 |
| Device Identification | |
| Proprietary Name: | T2® Ankle Arthrodesis Nail |
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod and Accessories, 21 CFR §888.3020 |
| Device Product Code | 87 HSB |

Description:

This 5 10(k) submission is a line extension to the T2® Nailing System to add an ankle arthrodesis nail and additional accessories to the system. The nails are inserted using an opened or closed technique and can be locked in static, dynamic or compression mode. The T2® Ankle Nails and accessories are intended for sungle use only.

#### Intended Use:

The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

- . Post-traumatic or primary Arthrosis
- . Previously infected arthrosis (second degree)
- Revision of Failed Ankle Arthrodesis .
- . Failed Total Ankic Replacement
- . Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
- . Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle
- . Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot
- . Ostheoartritis
- . Nonunions or Pseudarthrosis of hindfoot and distal tibia
- . Malunited tibial pilon fracture
- . Charcot foot
- t Severe endstage degenerative arthritis
- Severe defects after tumor resection .
- . Pantalar arthrodesis

### Substantial Equivalence:

The T2® Ankle Arthrodesis Nail is substantially equivalent to other legally marketed ankle nails in regards to design, materials, indications and operational principles. Testing demonstrated comparable mechanical strength to the predicate devices.

13

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's symbol, which consists of a stylized human figure with three arms extending upwards. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is written around the perimeter of the circle.

JUL 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vivian Kelly, RAC Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K051590

Trade/Device Name: T2® Ankle Arthrodesis Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: June 14, 2005 Received: June 15, 2005

Dear Ms. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(t) premainer is substantially equivalent (for the indications referenced above and nave ucterinined we arredicate devices marketed in interstate for use stated in the encrosure, to regars mannent date of the Medical Device American on to commence prior to May 20, 1776, the exactiance with the provisions of the Federal Food, Drug, devices that have been reclassified in acceraanse was now has he proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the device, busyer to the mail registration, listing of general controls provisions of the fiel her in and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controller Life 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I same oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease oe advised that I Dri 3 issuation of a complies with other requirements of the Act inal IDA has made a dolorimation an administered by other Federal agencies. You must or any receral statutes and regulations and admited to: registration and listing (21 comply with an the Not 3 requirements, 01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. Vivian Kelly, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket nothcation. The PDA miding of bassification 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 If you desire specific advice ion your access at [phone]. Also, please mote the regulation entitled, program and contact the Office of Comphane as (21 ) 11 (21 Part 807.97). You may obtain "Misoranting by relevelee to premainter for the Act from the Division of Small other general information on your responsible in the toll-free number [phone] or Manufacturers, Internet and Corses http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting 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): K051590

Device Name: T2® Ankle Arthrodesis Nail

Indications for Use:

The T2® Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to The T2" Ankle Arthrodesis Nail is mlended to thought the userse tarsal joints coupling the provide stabilization of the mind of specific indications include:

- Post-traumatic or primary Arthrosis .
- Previously infected arthrosis (second degree) .
- Revision of Failed Ankle Arthrodesis .
- Failed Total Ankle Replacement .
- Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) .
- Availar Processes or Neuromuscular Deformity or other neuromuscular disease with severe deformity . or instability of the ankle
- Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot .
- Ostheoartritis .
- Nonunions or Pseudarthrosis of hindfoot and distal tibia .
- Malunited tibial pilon fracture .
- Charcot foot .
- Severe endstage degenerative arthritis .
- Severe defects after tumor resection .
- Pantalar arthrodesis .

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (Part 21 CPR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
CONTINUE ON AND WRITE BELOW THIS LINEFERS NEEDED)

Concurrence of CPRH, Office of Device Evaluation (ODE)

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ence of CDRH, Office of Device Evaluation

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

1190 510(k) Number_