SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS

K092190 · Synthes (Usa) · KTT · May 11, 2010 · Orthopedic

Device Facts

• Record ID: K092190
• Device Name: SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: May 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

Device Story

External ring fixation system for orthopedic applications; utilizes wires, Schanz screws, rings, bolts, nuts, clamps, rods, connecting plates, hinges, standoffs, posts, and distractors. Fully customizable frame constructed per case. Used by surgeons in clinical settings for bone fixation and limb lengthening. MR Conditional status allows use in magnetic resonance environments. Benefits include stabilization of fractures and correction of deformities/defects in both adult and pediatric populations.

Clinical Evidence

No clinical data. Substantial equivalence supported by engineering performance evaluation, analysis, and MR safety testing in accordance with ASTM and IEC standards.

Technological Characteristics

External ring fixation system. Materials: implant grade titanium, elgiloy, stainless steel, carbon fiber. Modular assembly using wires, Schanz screws, rings, rods, and distractors. MR Conditional per ASTM F-2503, F-2052, F-2213, F-2182 and IEC 60601-2-33.

Indications for Use

Indicated for fracture fixation, pseudoarthrosis, non-unions of long bones, limb lengthening, and correction of bony or soft tissue deformities/defects in adult and pediatric patients.

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 Distraction Osteogenesis System
• Synthes Large External Fixation, MR Conditional

Submission Summary (Full Text)

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## 3.0 510(k) Summary

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| Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380 Phone: [phone]<br> | MAY 11 2010 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Jill R. Yelton, Regulatory Compliance Manager | |
| Device Name: | Synthes Distraction Osteogenesis System, MR Conditional with Expanded<br>Indications | |
| Classification: | 21 CFR Part 888.3030; Single/multiple component metallic bone fixation<br>appliances and accessories. | |
| Predicate Devices: | Synthes Distraction Osteogenesis System<br>Synthes Large External Fixation, MR Conditional | |
| Device<br>Description: | The Synthes Distraction Osteogenesis System, MR Conditional with<br>Expanded Indications is an external ring fixation system. The system is<br>comprised of wires and Schanz screws that are attached to rings with bolts,<br>nuts and/or clamps; rods that interconnect the rings; and connecting plates,<br>hinges, standoffs, posts, supports and distractors that complete the assembly of<br>the fixator. This system is a versatile system that is fully customizable. An<br>individualized frame should be constructed for each case to suit the specific<br>situation. The materials of construction for this system include implant grade<br>titanium, elgiloy, stainless steel and carbon fiber. | |
| Intended Use: | The Synthes Distraction Osteogenesis System, MR Conditional is intended for<br>fracture fixation (open and closed), pseudoarthrosis or non-unions of long<br>bones, limb lengthening by epiphyseal or metaphyseal distraction, correction<br>of bony or soft tissue deformities and correction of segmental bony or soft<br>tissue defects in adult and pediatric patients. | |
| Substantial<br>Equivalence | Information presented supports the substantial equivalence of the Synthes<br>Distraction Osteogenesis System, MR Conditional with Expanded Indications<br>to the predicate devices. The proposed devices have the same indications for<br>use with addition of MR Conditional and Pediatric, are similar in design,<br>incorporate the same fundamental product technology and are composed of<br>the same materials. MR testing was performed in accordance with current<br>ASTM Standards, F-2503, F-2052, F-2213 and F-2182 for marking and<br>standard test methods for displacement force, torque and RF heating, IEC<br>60601-2-33 for safety in a Magnetic Resonance Environment and Guidance for<br>Industry and FDA Staff, "Establishing Safety and Compatibility of Passive<br>Implants in the Magnetic Resonance (MR) Environment". Engineering<br>performance evaluation and analysis was performed comparing the proposed<br>devices to the predicate devices and an Engineering analysis was performed<br>and documentation provided to support addition of pediatric indications. The<br>results support substantial equivalence. | |

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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 features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

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

Synthes (USA) % Jill Yelton 1301 Goshen Parkway West Chester, Pennsylvania 19380

MAY 1 1 2010

Re: K092190

Trade/Device Name: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: April 16, 2010 Received: April 19, 2010

Dear Ms. Yelton:

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 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); 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 - Ms. Jill Yelton

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/ucm11.5809.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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

sincerely yours,

Raubare Briebup
for

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):

KOG 21900 (pg 141) -----------------------------------------------------------------------------------------------------------------------------------------------------------

## Device Name: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications

Indications for Use:

The Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

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)

Orita for nxm

ISION SER Division of Surgical Orthopedic. and Restorative Devices

510(k) Number K092190