SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE

K030390 · Synthes (Usa) · LXT · Apr 1, 2003 · Orthopedic

Device Facts

• Record ID: K030390
• Device Name: SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
• Applicant: Synthes (Usa)
• Product Code: LXT · Orthopedic
• Decision Date: Apr 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Combination Clamp and Dynamization Clip – MR Safe are generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for: ■ Stabilization of soft tissue injuries and open or closed fractures; ■ Polytrauma; ■ Vertically stable pelvic fractures of as a treatment adjunct for vertically unstable pelvic fractures; ■ Arthrodesis and osteotomies with soft tissue problems; ■ Failures of total joints; ■ Neutralization of fractures stabilized with limited internal fixation; ■ Non-unions/septic non-unions; ■ Intraoperative reduction/stabilization tool to assist with indirect reduction; ■ Unilateral rectilinear bone segment transport or leg lengthening.

Device Story

External fixation frame components; includes Large Combination Clamp and Dynamization Clip. Used to treat long bone and pelvic fractures; provides stabilization, reduction, and bone segment transport. Dynamization Clip allows for controlled movement during healing. Compatible with 11.0 mm carbon fiber rods and 4-6 mm Schanz screws. Designed for use in MR environment. Operated by surgeons in clinical settings. Provides mechanical stabilization of bone segments; facilitates fracture healing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Clamps constructed from stainless steel, titanium alloy, and cobalt alloy; Dynamization Clip constructed from cobalt alloy. Mechanical fixation device; MR safe design. Compatible with 11.0 mm carbon fiber rods and 4-6 mm Schanz screws.

Indications for Use

Indicated for patients requiring external fixation for long bone and pelvic fractures, including soft tissue injuries, polytrauma, arthrodesis, osteotomies, joint failure, non-unions, and bone segment transport or leg lengthening.

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 Combination Clamp and Dynamization Clip

Submission Summary (Full Text)

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APR 0 1 2003

30390

Page _________________________________________________________________________________________________________________________________________________________________________

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Bonnie Smith |
| Device Name: | Synthes Large Combination Clamp and Dynamization Clip – MR Safe |
| Classification: | Class II, 21 CFR 888.3030: "Single/multiple component bone fixation<br>appliances and accessories." |
| Predicate Device: | Synthes Combination Clamp and Dynamization Clip |
| Device Description: | Synthes Large Combination Clamp and Dynamization Clip-MR Safe are<br>components of an external fixation frame that forms a construct intended to<br>treat long bone and pelvic fractures. The Dynamization Clip is an accessory<br>to the clamp that allows dynamization during bone healing. These devices<br>are intended for use in the MR environment. Frame components accept<br>Synthes Ø11.0 mm carbon fiber rods and Synthes Schanz screws in<br>diameters of 4 - 6 mm. |
| Intended Use: | Synthes Combination Clamp and Dynamization Clip – MR Safe are<br>generally intended to be used in the construction of an external fixation<br>frame to treat long bone and pelvic fractures. Specifically, the Synthes<br>Combination Clamp with Dynamization Clip is intended for:<br>■ Stabilization of soft tissue injuries and open or closed fractures;<br>■ Polytrauma;<br>■ Vertically stable pelvic fractures of as a treatment adjunct for<br>vertically unstable pelvic fractures;<br>■ Arthrodesis and osteotomies with soft tissue problems;<br>■ Failures of total joints;<br>■ Neutralization of fractures stabilized with limited internal fixation;<br>■ Non-unions/septic non-unions;<br>■ Intraoperative reduction/stabilization tool to assist with indirect reduction;<br>■ Unilateral rectilinear bone segment transport or leg lengthening. |
| Materials: | Clamps - Stainless steel, titanium alloy and cobalt alloy<br>Dynamization Clip - Cobalt alloy |

3.0

510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 0 1 2003

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301

Re: K030390

Trade/Device Name: Synthes Large Combination Clamp and Dynamization Clip - MR Safe Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: February 4, 2003 Received: February 5, 2003

Dear Ms. Smith:

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. Iisting 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

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Page 2 -- Ms. Bonnie J. Smith

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. 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 Office of 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milhurn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known):

Device Name:

INDICATIONS:

Image /page/3/Picture/5 description: The image shows a document with the title "Division Sign-Off" and the subtitle "Division of General, Restorative and Neurological Devices". The document also includes the text "510(k) Number" followed by the number "K050390". There is a signature above the title, which appears to read "Mark Miller".

Ko30390

Synthes (USA) Synthes Large Combination Clamp and Dynamization Clip - MR Safe

Synthes Combination Clamp and Dynamization Clip - MR Safe are generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for:

- · Stabilization of soft tissue injuries and open or closed fractures;
- * Polytrauma;
- · Vertically stable pelvic fractures as a treatment adjunct for vertically unstable pelvic fractures;
- . Arthrodesis and osteotomies with soft tissue problems;
- · Failures of total joints;
- · Neutralization of fractures stabilized with limited internal fixation;
- · Non-unions;
- · Intraoperative reduction/stabilization tool to assist with indirect reduction;
- · Unilateral rectilinear bone segment transport or leg lengthening.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Premarket Notification 510(k): CONFIDENTIAL Synthes (USA) Large Combination Clamp and Dynamization Clip - MR Safe

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