NEWDEAL ANKLE NAIL

K050882 · New Deal, S.A. · HSB · May 27, 2005 · Orthopedic

Device Facts

• Record ID: K050882
• Device Name: NEWDEAL ANKLE NAIL
• Applicant: New Deal, S.A.
• Product Code: HSB · Orthopedic
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: - Post-traumatic and degenerative arthritis involving both ankle and subtalar joints - rheumatoid arthritis - revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body - revision of failed total ankle arthroplasty with subtalar intrusion - talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) - avascular necrosis of the talus - Neuroarthropathy or neuropathic ankle deformity - severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease - severe pilon fractures with trauma to the subtalar joint

Device Story

Newdeal Ankle Nail is a straight, cannulated intramedullary fixation rod designed for tibiotalocalcaneal arthrodesis and hindfoot/distal tibia trauma. Device is implanted by a surgeon via insertion through the calcaneus. System includes nail (11-13mm diameter; 150-180mm length) and locking cortical screws (5mm diameter; 20-110mm length). All components are manufactured from Ti-6Al-4V ELI alloy. Device provides mechanical stabilization of the ankle and subtalar joints to facilitate fusion or fracture healing. Clinical benefit includes correction of deformity and stabilization of complex hindfoot pathologies.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Cannulated intramedullary nail; diameters 11-13mm, lengths 150-180mm. Material: Ti-6Al-4V ELI alloy. Features proximal and distal locking holes for 5mm diameter cortical screws. Mechanical fixation device.

Indications for Use

Indicated for patients requiring tibiotalocalcaneal arthrodesis or treatment of hindfoot and distal tibia trauma, including post-traumatic/degenerative arthritis, rheumatoid arthritis, failed prior arthrodesis or total ankle arthroplasty, talar deficiency, avascular necrosis, neuroarthropathy, neuromuscular deformities (e.g., equinovarus, paralysis), and severe pilon fractures.

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.

Predicate Devices

• Smith & Nephew ReVision Nail (K983942)
• DePuy VersaNail (K023115)
• Biomet Ankle Arthrodesis Nail (K021786)

Submission Summary (Full Text)

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

KOSO882

Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in a bold, sans-serif font, with the "®" symbol next to it. To the left of the word is a circle with five dots around it, one of which is shaded gray.

MAY 2 7 2005

## 510(k) SUMMARY

### Applicant's Name and Address: A.

Newdeal SA Newaterra LifeSciences Company 10, place d'Helvétie 69006 LYON FRANCE Tel.: [phone] Fax: [phone] ESTABLISHMENT REGISTRATION NUMBER: 9615741

### Authorized Agent and Official Contact Person: B.

Judith O'Grady Sr. VP Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA TEL: [phone] FAX: [phone]

- Date Summary Prepared: C. April 6, 2005
- Name of Device: D. Proprietary Name: Newdeal Ankle Nail

Common Name: Ankle nail

Classification Name and Reference: Intramedullary fixation rod (21 CFR 888.3020)

Device Product Code: HSB

Proposed Regulatory Class: Class II

Panel: Orthopedic

- Device Description E.
Device Description
The Newdeal Ankle Nail is a straight, cannulated intramedullary nailable in The Newcal 11mm, 12mm and 13mm, and lengths of 150mm and 180mm. dialiciers of 11 mm, TEMP proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long by 5mm increment. Screws Shim anameter, the end cap and the locking screws are all made from Ti-6Al-4V ELI alloy.

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

The Newdeal Ankle Nail is to be implanted by insertion through the calcaneus, the The Newton Ankie Fran is to to otalocalcaneal arthrodesis, for correction of deformity, or fixation of fractures.

K050882

#### Indications for Use F.

Indications for USC
The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and The Newtrair Annue Nair nindfoot and distal tibia. Examples include:

- liment of traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis -
- Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- nisurioient tailer total ankle arthroplasty with subtalar intrusion -
- Revision of faired total ons (requiring a tibiocalcaneal arthrodesis) -
- Avascular necrosis of the talus -
- Neuroarthropathy or neuropathic ankle deformity -
- Newroalthropatity of nearspants. Inclipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- pararyons or ofractures with trauma to the subtalar joint -

#### Substantial Equivalence G.

Substantial Equivalence indications for use and dimensions with the following predicate devices:

| Smith & Nephew | ReVision Nail | K983942 |
|----------------|------------------------|---------|
| DePuy | VersaNail | K023115 |
| Biomet | Ankle Arthrodesis Nail | K021786 |

### Comparison of Technological Characteristics H.

Comparison of 1 cennotogical Onf the Newdeal Ankle Nail are the same as the The technological charges in terms of intended use and design. All of these nails have the following characteristics:

- Holed for proximal and distal locking -
- Made from Titanium alloy or stainless steel -
- Cannulated -
- Equivalent size range -
- Intended to be implanted for tibiocalcaneal arthrodesis -

#### Summary of Studies I.

Sunninary of Statures Ankle Nail meets our acceptance criteria.

#### J. Conclusion

Conclusion & Nephew ReVision nail, K983942, DePuy ACE VersaNail, K023115 and Biomet Ankle Arthrodesis Nail, K021786.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.

MAY 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newdeal SA C/o Ms. Judith E. O'Grady Senior V.P Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K050882

Trade/Device Name: Newdeal Ankle Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 6, 2005 Received: April 7, 2005

Dear Ms. O'Grady:

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. Judith E. O'Grady

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your of substantial equivalence of your device 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 If you dealer specific and Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ecterers, 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,

Sincerely yours,

Miriam C. Provost, Ph.D.

m C. Provost. Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

## 510(k) Number (if known):

# Device Name: NEWDEAL ANKLE NAIL

## Indications For Use:

The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

- Post-traumatic and degenerative arthritis involving both ankle and subtalar ioints
- rheumatoid arthritis -
- revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- revision of failed total ankle arthroplasty with subtalar intrusion ー
- talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -
- avascular necrosis of the talus -
- Neuroarthropathy or neuropathic ankle deformity ー
- severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- severe pilon fractures with trauma to the subtalar joint -

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 IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| | |
| Division Sign-Off) | |
| Division of General, | |
| and Neurological Devices | |

Page 1 of 1

5110(1) Number K050882