SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES

K080522 · Synthes (Usa) · HRS · May 23, 2008 · Orthopedic

Device Facts

• Record ID: K080522
• Device Name: SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Device Story

Synthes 3.5 mm LCP Distal Tibia T Plates are metallic bone fixation devices contoured for distal tibia anatomy. Plates feature combination and locking screw holes to accommodate various Synthes screws. Used by surgeons in clinical settings to stabilize bone fractures, osteotomies, or non-unions. Locking mechanism provides stability, particularly beneficial in osteopenic bone where traditional fixation may fail. Device is implanted to facilitate bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plate; materials: stainless steel and titanium; features combination and locking screw holes; anatomical contouring for distal tibia; non-sterile (implied); mechanical fixation via screws.

Indications for Use

Indicated for patients with fractures, osteotomies, and non-unions of the distal tibia, 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 One Third Tubular LCP Plate
• Synthes 3.5 mm LCP Straight Plate

Submission Summary (Full Text)

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K080522

MAY 2 3 2008 2008 2008

| 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]<br>FAX [phone] |
| | Device Name: | Synthes 3.5 mm LCP Distal Tibia T Plates |
| | Classification: | Class II, §888.3030 - Single/multiple component metallic bone<br>fixation appliances and accessories |
| | Predicate Device: | Synthes One Third Tubular LCP Plate<br>Synthes 3.5 mm LCP Straight Plate |
| | Device Description: | Synthes 3.5 mm LCP Distal Tibia T Plates are contoured to match<br>the anatomy of the distal tibia. The plates have both combination<br>and locking screw holes which accept various Synthes screws.<br>They are available in stainless steel and titanium, in a variety of<br>lengths. |
| | Intended Use: | The Synthes LCP Distal Tibia T Plates are indicated for fractures,<br>osteotomies, and non-unions of the distal tibia, especially in<br>osteopenic bone. |
| | Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

® SYNTHES®

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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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 3 - 2008

Synthes (USA) % Ms. Sheri L. Musgung Regulatory Affairs Managcr 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K080522 Trade/Device Name: Synthes 3.5 mm LCP Distal Tibia T Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 25, 2008 Received: February 26, 2008

Dear Ms. Musgung:

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. Musgung

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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. 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):

Device Name:

Synthes 3.5 mm LCP Distal Tibia T Plates

Indications for Use:

The Synthes 3.5 mm LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Orde forman

(Division Sign-Of Division of General, Restorative and Neurological Devices

**510(k) Number** K080522