SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES

K081353 · Synthes (Usa) · HRS · Jul 23, 2008 · Orthopedic

Device Facts

• Record ID: K081353
• Device Name: SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Jul 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes TomoFix TM Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

Device Story

TomoFix Medial Distal Femur Plates are titanium bone fixation implants; part of the TomoFix Osteotomy System. Plates are anatomically contoured for the medial distal femur; available in left and right versions. Features include locking holes in the head and combination locking/dynamic compression holes in the shaft. Used by surgeons in clinical settings to provide stable fixation for osteotomies, bone/joint deformities, fractures, and malalignment. Device stabilizes bone segments to facilitate healing and correct alignment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design characteristics.

Technological Characteristics

Titanium bone plates; anatomically contoured for medial distal femur. Features locking holes and combination locking/dynamic compression holes. Metallic bone fixation appliance (21 CFR 888.3030).

Indications for Use

Indicated for patients requiring open or closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, or medial/lateral distal femur, and for treatment of bone/joint deformities, fractures, and malalignment due to injury or disease (e.g., osteoarthritis).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes TomoFix Osteotomy System
• Synthes Large Fragment Dynamic Compression Locking System
• Synthes LCP Distal Femur Plates

Submission Summary (Full Text)

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| 510(k) Summary | | Page | 1 | of | 1 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|---|----|-------------|
| Sponsor: | Synthes (USA)<br>Karl J. Nittinger<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | | | | JUL 23 2008 |
| Device Name: | Synthes (USA) TomoFix ^TM Medial Distal Femur Plates | | | | |
| Classification: | Class II; §888.3030 - Single / multiple component metallic bone<br>fixation appliance and accessories. | | | | |
| Predicate Device: | Synthes TomoFix ^TM Osteotomy System<br>Synthes Large Fragment Dynamic Compression Locking System<br>Synthes LCP Distal Femur Plates | | | | |
| Device Description: | The Synthes TomoFix ^TM Medial Distal Femur Plates are part of the<br>Synthes TomoFix ^TM Osteotomy System which is a system<br>consisting of titanium plates with locking and combination holes<br>designed to provide stable fixation of osteotomies close to the knee.<br>The TomoFix ^TM Medial Distal Femur Plates consist of titanium<br>plates anatomically contoured to fit the medial distal femur. The<br>plates are available in right and left versions and feature locking<br>holes in the head and combination locking/dynamic compression<br>holes in the shaft. | | | | |
| Intended Use: | Synthes TomoFix ^TM Osteotomy System is intended for open and<br>closed wedge osteotomies of the medial proximal tibia, lateral<br>proximal tibia, medial and lateral distal femur, treatment of bone<br>and joint deformities, fractures, and malalignment caused by injury<br>or disease such as osteoarthritis. | | | | |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. | | | | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Pkwy. West Chester, PA 19380

JUL 2 3 2008

Re: K081353 Trade/Device Name: Synthes (USA) TomoFix™ Medial Distal Femur Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: May 12, 2008 Received: May 14, 2008

Dear Mr. Nittinger:

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.

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## Page 2 - Mr. Karl J. Nittinger

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.

Sincerely yours.

Mark N. Millman

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

K081353 (pg 1/1) 510(k) Number (if known):

Device Name: Synthes (USA) TomoFix™ Medial Distal Fernur Plates

Indications for Use:

Synthes TomoFixTM Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

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, Re .. ... and Neurological Devices

**510(k) Number** 108313