SYNTHES SMALL COBINATION CLAMP-MR SAFE

K031724 · Synthes (Usa) · KTT · Jul 14, 2003 · Orthopedic

Device Facts

• Record ID: K031724
• Device Name: SYNTHES SMALL COBINATION CLAMP-MR SAFE
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jul 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius.

Device Story

Synthes Small Combination Clamp - MR Safe is a mechanical component of an external fixation frame system. It connects Ø4.0 mm carbon fiber rods, various diameter Schanz screws (4.0/4.0, 4.0/3.0, 4.0/2.5 mm), and Ø2.5 mm K-wires to stabilize bone fractures. Used in clinical settings for orthopedic trauma treatment of hand, wrist, mandible, and foot. Designed for compatibility with the MR environment. Operated by surgeons to construct rigid fixation frames; provides structural support for bone healing; enables patient stabilization during and after fracture management.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical bone fixation clamp. Materials: stainless steel, titanium alloy, and cobalt alloy. Compatible with Ø4.0 mm carbon fiber rods, specific Schanz screws, and Ø2.5 mm K-wires. Designed for MR safety.

Indications for Use

Indicated for patients with fractures of the distal radius (including open, comminuted, bilateral, or those with soft tissue/vascular/neural injury), fractures and dislocations of the hand, wrist, mandible, and foot, and secondary deformity of the distal radius following failed closed reduction and casting.

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

• Imedica's TransFx Small External Fixation System

Submission Summary (Full Text)

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JUL 1 4 2003

K031724

Page 1 of 1

| 3.0 | 510(k) Summary | Page | 1 | of | 1 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|---|----|---|
| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] | | | | |
| Contact: | Bonnie Smith | | | | |
| Device Name: | Synthes Small Combination Clamp - MR Safe | | | | |
| Classification: | Class II, 21 CFR 888.3030: "Single/multiple component bone fixation appliances and accessories." | | | | |
| Predicate Device: | Imedica's TransFx Small External Fixation System | | | | |
| Device Description: | Synthes Small Combination Clamp -MR Safe is a component of an external fixation frame that forms a construct generally intended to treat the hand, wrist, mandible and foot. This device is intended for use in the MR environment. Frame components accept Synthes Ø4.0 mm carbon fiber rods, Synthes Schanz Screws in diameters of 4.0/4.0, 4.0/3.0 and 4/0/2.5 mm and Synthes Ø2.5 mm K-wires. | | | | |
| Intended Use: | Intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius. | | | | |
| Materials: | Clamps - Stainless steel, titanium alloy and cobalt alloy | | | | |
| Substantial<br>Equivalence | Documentation is provided which demonstrates that the Synthes Small Combination Clamp -MR Safe is substantially equivalent* to other legally marketed Synthes devices. | | | | |

* The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three overlapping lines, possibly representing an abstract human figure or a symbol of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2003

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

Re: K031724 Trade/Device Name: Synthes (USA) Small Combination Clamp - MR Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: May 30, 2003 Received: June 3, 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, 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

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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.

Miriam C. Provost

(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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## 2.0 Indications for Use Statement

K0317d24/

510(k) Number (if known):

DEVICE NAME:

Synthes (USA) Small Combination Clamp - MR Safe

INDICATIONS:

Synthes Small Combination Clamps – MR Safe are intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius.

Muriam C. Provost

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

K031724 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

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