SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL

K100676 · Synthes (Usa) · HRS · Apr 8, 2010 · Orthopedic

Device Facts

• Record ID: K100676
• Device Name: SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Apr 8, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes TomoFix™ 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 High Tibia Plate, Small is a metallic bone fixation appliance; part of the TomoFix Osteotomy System. Device consists of titanium plates with locking and combination holes. Used by surgeons in clinical settings to provide stable fixation close to the knee during osteotomy procedures. Plate stabilizes bone segments to facilitate healing of deformities, fractures, or malalignment. Surgeon selects and implants the plate to maintain bone alignment; provides mechanical support during the bone healing process.

Clinical Evidence

Bench testing only. Preclinical testing included dynamic fatigue and static 3-point bend testing comparing the subject plate to the predicate device to verify mechanical performance.

Technological Characteristics

Metallic bone fixation plate; titanium construction; locking and combination hole design; dimensions/form factor specific to 'Small' variant; mechanical fixation principle; non-powered; non-sterile (implied, requires sterilization).

Indications for Use

Indicated for patients requiring open or closed wedge osteotomies of the medial/lateral proximal tibia or medial/lateral distal femur, and treatment of bone/joint deformities, fractures, or 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 (USA) TomoFix™ Osteotomy System

Submission Summary (Full Text)

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K100676(pg 1/1)

3.0 510(k) Summary Page Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 APR - 8 2010 [phone] Karl J. Nittinger Contact: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 [phone] Synthes (USA) TomoFix™ Medial High Tibia Plate, Small Device Name: Classification: Class II, §888.3030 - Single / multiple component metallic bone fixation appliance and accessories. HRS (Plate, Fixation, Bone) Classification Product Code: Synthes (USA) TomoFixTM Osteotomy System Predicate Devices: The Synthes (USA) TomoFix™ Medial High Tibia Plate is a part of Device the Synthes TomoFix™ Osteotomy System which is a system Description: consisting of titanium plates with locking and combination holes designed to provide stable fixation close to the knee. The Synthes (USA) TomoFix™ Osteotomy System is intended for Indications for open and closed wedge osteotomies of the medial proximal tibia, Use: 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. . Information presented supports the substantial equivalence of the Substantial TomoFix Medial High Tibia Plate, Small to the predicate device. The Equivalence: proposed plate has the same indications for use, is similar in shape/design, incorporates the same fundamental product technology and is composed of the same materials. Additionally, preclinical testing - including dynamic fatigue and static 3-point bend testing was performed comparing the proposed plate to the predicate plate and the results support substantial equivalence.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

## APR - 8 2010

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

Re: K100676

Trade/Device Name: Synthes (USA) TomoFix™ Medial High Tibia Plate, Small Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: February 18, 2010 Received: March 10, 2010

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 marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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, inst a of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract and warranties. We remind you, however, that device labeling must be truthful and not midler

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 devine 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 not 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

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Page 2 – Mr. Karl J. Nittinger

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark M. Mulkerner

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:

2.0

Synthes (USA) TomoFix™ Medial High Tibia Plate, Small

Indications for Use:

The Synthes TomoFix™ 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)

Soutte for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100676