SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM

K051678 · Synthes (Usa) · HSB · Sep 21, 2005 · Orthopedic

Device Facts

• Record ID: K051678
• Device Name: SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Device Story

Synthes Hindfoot Arthrodesis Nail System consists of titanium cannulated arthrodesis nails, 6.0 mm locking screws, and end caps. System utilizes commercially available spiral blades, locking screws, and locking bolts to secure nail within bone; prevents rotation and provides axial compression. Intended for surgical use by orthopedic surgeons to facilitate tibiotalocalcaneal arthrodesis. Device provides internal fixation to stabilize foot/ankle complex, promoting fusion in patients with severe deformity, instability, or degenerative conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Titanium cannulated arthrodesis nails, 6.0 mm locking screws, and end caps. Intramedullary fixation rod design. Mechanical stabilization via locking screws and spiral blades.

Indications for Use

Indicated for patients requiring tibiotalocalcaneal arthrodesis due to severe foot/ankle deformity, arthritis, instability, or skeletal defects post-tumor resection, including Charcot's Foot, talar avascular necrosis, failed joint replacement/fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.

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

• Biomet Inc. - Titanium Ankle Arthrodesis Nail
• Synthes - 6.0 mm Locking Screws (accessory in Titanium Distal Femoral Nail System)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo. There is a horizontal line below the word "SYNTHES".

Revised 510(k) Summary

## K051678

사용

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| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Hindfoot Arthrodesis Nail System |
| Classification: | Class II, §888.3020 - Intramedullary Fixation Rod |
| Predicate Devices: | Biomet Inc. - Titanium Ankle Arthrodesis Nail<br>Synthes - 6.0 mm Locking Screws (accessory in Titanium Distal<br>Femoral Nail System) |
| Device Description: | Synthes Hindfoot Arthrodesis Nail System is composed of<br>titanium cannulated arthrodesis nails, 6.0 mm Locking Screws,<br>and end caps. Synthes commercially available spiral blades,<br>locking screws, and locking bolts are used to secure the nail in the<br>bone, preventing rotation and axial compression. |
| Intended Use: | Synthes Hindfoot Arthrodesis Nail System is intended to facilitate<br>tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity,<br>arthritis, instability, and skeletal defects after tumor resection.<br>These include, but are not limited to Neuro-osteoarthropathy<br>(Charcot's Foot), Avascular Necrosis of the talus, failed joint<br>replacement, failed ankle fusion, distal tibia fracture non-unions,<br>Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the Synthes<br>Hindfoot Arthrodesis Nail System to be substantially equivalent to<br>other legally marketed devices. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sheri L. Musgnung Senior Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K051678 . R051678
Trade/Device Name: Synthes (USA) Hindfoot Arthrodesis Nail System Regulation Name: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 21, 2005 Reccived: June 23, 2005

Dear Ms. Musgnung:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in We have reviewed your Section - 10(x) premaince netibiation worked in intentions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule to regary maneted povice Americal Device Ameral Hood Drug commerce prof to May 20, 1776, the enternets and the provisions of the Federal Food. Drug, devices that have been recure approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval aranges of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls, provisions of You may, merelore, market the device, salger to we s
general controls provisions of the Act include requirements for annual registration, and general controls provisions of the Floridae required required against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), If your device is classified (see a00%) into existing major regulations affecting your device. FDA il may be subject to such additional Controllar Bloghing Chile 21, Parts 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to can be found in the Code of Peachartegories concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence ectermination does not mean Please be advised that TDA s issuates of a stations with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decertimation that your cerced by other Federal agencies. You must a or iny recerdi statutes and regulations achinities or registration and listing (21)
comply with all the Act's requirements, including, but not issues seguirements as set comply with an the Act s requirements, memormalice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing phartice the electron CFR Part 807), labeling (21 CFR Part 820); and 11 applicable, the electronic form in the quality systems (Q5) roganations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 – Ms. Sheri L. Musgnung

This letter will allow you to begin marketing your device as described in your Section 510(k)
The Cases of the Cases of a first of a between of your device to a legally This letter will allow you to begin minketing your antinee of your device to a legally
premarket notification. The FDA finding of substantial equive and thus, permits your premarket notification. The FDA Inding of substantial of the survey of device to proceed to the market.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our nabing vegen note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the reg contact the Office of Compliance at [phone] Part 807.97). You may obtain
"Misbranding by reference to premarket notification in from 807.97). You may obtain "Misbranding by reference to premiset nothlication" (27 Of from the Division of Small
other general information on your responsibilities under the Act from the 1800) 638-204 other general information on your responsionings and its foll-free mumber [phone] or 1988)
Manufacturers, International and Consumer Assistance at its formations html Manufacturers, International and Consumer Assistance to to tor treating on the many of index.html.
[phone] or at its Internet address http://www.fda.gov/cdch/industry/

Sincerely yours,

Z

for 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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Image /page/3/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a registered trademark symbol next to the "S" at the end of the word "SYNTHES". A horizontal line runs beneath the entire logo.

Indications for Use

K051672

510(k) Number (if known):

Synthes (USA) Hindfoot Arthrodesis Nail System

INDICATIONS FOR USE:

Device Name:

The Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Prescription Use X (Per 21 CFR 801.109)

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)

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

510(k) Number K051678

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