SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES

K083213 · Synthes (Usa) · HRS · Dec 30, 2008 · Orthopedic

Device Facts

• Record ID: K083213
• Device Name: SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Dec 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.

Device Story

Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are metallic bone fixation implants designed for distal fibula stabilization. Plates feature low-profile geometry contoured to distal fibula and diaphyseal anatomy. Integrated Combi holes accommodate both locking and non-locking screws (3.5 mm cortex, 3.5 mm self-tapping, 3.5 mm shaft, 3.5 mm locking, 4.0 mm cancellous, 2.4 mm/2.7 mm locking, and 2.4 mm/2.7 mm self-tapping cortex screws). Used by orthopedic surgeons in clinical settings to provide rigid fixation for fractures, osteotomies, or non-unions, particularly in osteopenic bone where traditional fixation may be less effective. Device provides mechanical stability to facilitate bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plates available in stainless steel and titanium. Features low-profile design with Combi holes for locking and non-locking screw compatibility. Dimensions vary by length. Mechanical fixation principle.

Indications for Use

Indicated for patients with fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, particularly those with osteopenic bone.

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 2.7 mm/3.5 mm LCP Distal Fibula Plates
• Synthes One Third Tubular LCP Plate

Submission Summary (Full Text)

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DEC 3 0 2008

## K083213

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | |
| Contact: | Sheri L. Musgnung<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | |
| Device Name: | Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications | |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone<br>fixation appliances and accessories | |
| Predicate Device: | Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates<br>Synthes One Third Tubular LCP Plate | |
| Device Description: | Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to<br>match the anatomy of the distal fibula and diaphyseal region. The<br>plates feature a low-profile design and Combi holes (Dynamic<br>Compression Plate holes combined with locking screw holes),<br>which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm<br>shaft, 3.5 mm locking screws, and 4.0 mm cancellous screws. The<br>plates locking holes accept 2.4 mm, 2.7 mm locking screws along<br>with 2.4 mm and 2.7 mm self-tapping cortex screws. The plates<br>are available in stainless steel and titanium, as well as a variety of<br>lengths. | |
| Intended Use: | The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are<br>indicated for fractures, osteotomies, and non-unions of the<br>metaphyseal and diaphyseal region of the distal fibula, especially<br>in osteopenic bone. | |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes (USA) % Ms. Sheri L. Musgnung 1301 Goshen Parkway West Chester, PA 19380

DEC 3 0 2008

Re: K083213

Trade/Device Name: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: HRS, HWC Dated: October 30, 2008 Reccived: October 31, 2008

Dear Ms. Musgnung:

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 - Ms. Sheri L. Musgnung

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 the reporting 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 Y. 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

510(k) Number (if known):

K083213

Device Name:

Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates

Indications for Use:

The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.

Prescription Use (Per 21 CFR 801.109)

ﺎﻳﺔ

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)

Daird Krone for mscu

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

**510(k) Number** K063213

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