SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM

K023802 · Synthes (Usa) · HRS · Jan 28, 2003 · Orthopedic

Device Facts

• Record ID: K023802
• Device Name: SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar, combination of lateral wedge and depression, and fractures with associated shaft fracture.

Device Story

Bone fixation system for proximal tibia; consists of titanium plates, cannulated locking/conical screws, and solid locking screws. Plates feature limited contact, low-profile design contoured to proximal tibia anatomy; include threaded screw holes and 2.0 mm holes for k-wires or sutures. Shaft holes accept various screw types for dynamic compression and locking. Used by orthopedic surgeons in clinical settings to stabilize fractures and promote healing in nonunion/malunion cases. Provides mechanical stabilization of bone segments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium bone fixation plates and screws. Features limited contact, low-profile design. Includes combination screw holes for dynamic compression and locking. System components include 4.5 mm plates, 5.0 mm cannulated locking/conical screws, and 4.0/5.0 mm solid locking screws.

Indications for Use

Indicated for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar, combination of lateral wedge and depression, and fractures with associated shaft fractures.

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 LCP Proximal Tibia Plating System
• Synthes Large Fragment LCP T- Plate

Submission Summary (Full Text)

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JAN 2 8 2003

K023802
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### Summary of Safety and Effectiveness Information 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes 4.5 mm Titanium LCP Proximal Tibia Plating System |
| CLASSIFICATION: | Class II, §888.3030 - Plate, Fixation, Bone<br>Class II, §888.3040 - Smooth or threaded metallic bone fixation fastener |
| PREDICATE DEVICE: | Synthes LCP Proximal Tibia Plating System<br>Synthes Large Fragment LCP T- Plate |
| DEVICE DESCRIPTION: | The Synthes Titanium 4.5mm LCP Proximal Tibia Plating System consists<br>of 4.5 mm Titanium LCP Proximal Tibia Plates, 5.0 mm Titanium<br>Cannulated Locking and Conical screws, and 4.0 mm and 5.0 mm Titanium<br>Solid Locking screws .<br>The Tibia Plates are contoured to match the anatomy of the proximal tibia<br>with a limited contact low profile design. These are plates designed for<br>either the right or left tibia in a variety of shaft lengths. The plate head has<br>threaded screw holes and 2.0 mm holes for preliminary fixation with k-<br>wires, or meniscal repair with sutures.<br>The plate shaft has combination screw holes (dynamic compression and<br>locking screw holes), that accept 4.5 mm cortex, 6.5 mm cancellous, 5.0<br>mm cannulated locking, 5.0 mm conical, and 4.0 mm & 5.0 mm locking<br>screws.<br>A titanium screw nut is also utilized with this system. |
| INTENDED USE: | The Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is<br>intended for treatment of nonunions, malunions, and fractures of the<br>proximal tibia, including simple, comminuted, lateral wedge, depression<br>medial wedge, bicondylar, combination of lateral wedge and depression,<br>and fractures with associated shaft fracture. |
| MATERIAL: | Titanium |

Confidential

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2003

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

Re: K023802

Trade/Device Name: Synthes 4.5 mm Titanium LCP Proximal Tibia Plating System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 13, 2002 Received: November 14, 2002

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

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Page 2 - Ms. Lisa M. Boyle

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). Other general information on your responsibilities under the Act may be obtained 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,

O Mark A Wilkerson

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

# KON3802

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| 510(k) Number (if known): | |
|---------------------------|--|
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Synthes (USA) 4.5 mm Titanium LCP Proximal Tibia Plating System Device Name:

Indications/Contraindications:

The Synthes 4.5 mm Titanium LCP Proximal Tibia System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

for Mark N. Melkerson
Division Sign Off

Confidential