SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES

K032269 · Synthes (Usa) · HRS · Sep 17, 2003 · Orthopedic

Device Facts

• Record ID: K032269
• Device Name: SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split- type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.

Device Story

Metallic bone fixation plate; contoured for medial proximal tibia anatomy; limited contact low-profile design. Used by orthopedic surgeons in clinical settings for fracture stabilization. Plate head features 2.0 mm holes for preliminary k-wire fixation or suture-based meniscal repair. Provides structural support to bone segments to facilitate healing; aids in management of complex tibial fractures and nonunions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: Titanium and Stainless Steel. Design: Contoured, limited contact, low-profile plate. Features: 2.0 mm holes for k-wires or sutures. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with metaphyseal fractures, split-type fractures, medial split fractures with depressions, or split/depression fractures of the medial tibia plateau. Also indicated for fixation of osteopenic bone, nonunions, and malunions of the medial proximal tibia and tibia shaft.

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 (USA) Large Fragment LCP T- Plate

Submission Summary (Full Text)

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## SEP 1 7 2003

032269
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## Summary of Safety and Effectiveness Information 3.0

| SPONSOR: | Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone] Contact: Lisa M. Boyle |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates |
| CLASSIFICATION: | Class II, §888.3030 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) Large Fragment LCP T- Plate |
| DEVICE DESCRIPTION: | The Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates are contoured to match the anatomy of the medial proximal tibia with a limited contact low profile design. The plates are designed for either the right or left medial proximal tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plate head exhibits 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures. |
| INTENDED USE: | The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split- type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft. |
| SUBSTANTIAL EQUIVALENCE | Comparative information presented supports substantial equivalence. |
| MATERIAL: | Titanium and Stainless Steel |

Confidential

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Image /page/1/Picture/1 description: The image shows a black and white logo. The logo consists of three stylized birds in flight, arranged in a row and angled upwards to the right. The birds are enclosed within a circle. The text "PUBLIC HEALTH SERVICE" is written around the top half of the circle.

Public Health Service

SEP 1 7 2003

Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850

Ms Lisa M Boyle Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301

Re: K032269

Trade/Device Name: Synthes (USA) 3.5 / 4.5mm LCP* Medial Proximal Tibia 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: July 22, 2003 Received: July 23, 2003

Dear Ms. Boyle:

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 forth in the quality systems (OS) 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. Lisa M. Boyle

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 vours.

Sincerely yours,

Mark N. Millikan

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

Page _________________________________________________________________________________________________________________________________________________________________________

030669 510(k) Number (if known):

Device Name: Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates

Indications/Contraindications:

The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of qsteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.

(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
Mark A Milkenos

General. Restorative and Neurological Device

510(k) .

Confidential