SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION

K052390 · Synthes (Usa) · HRS · Oct 7, 2005 · Orthopedic

Device Facts

• Record ID: K052390
• Device Name: SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, osteopenic bone, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

Device Story

Synthes LCP Proximal Tibia Plates are metallic bone fixation implants designed for surgical treatment of proximal tibia fractures and related conditions. Plates feature a limited-contact, low-profile design contoured to match proximal tibia anatomy. Available in left and right configurations with shaft lengths from 298 mm to 370 mm and 16 to 20 shaft holes. Used by orthopedic surgeons in clinical/OR settings to stabilize bone segments, promoting healing in nonunions, malunions, or osteopenic bone. Device provides mechanical support to bone structure; does not involve electronic processing or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plate; limited-contact, low-profile design; contoured for proximal tibia anatomy; lengths 298-370 mm; 16-20 shaft holes; non-electronic; mechanical fixation.

Indications for Use

Indicated for patients requiring surgical fixation of the proximal tibia for nonunions, malunions, osteopenic bone, tibial osteotomies, and various fracture types including simple, comminuted, lateral/medial wedge, depression, bicondylar, periprosthetic, and 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 Plates

Submission Summary (Full Text)

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## OCT 7 - 2005

K052390

## 3.0 510(k) Summary

Page _________ of ______ of __________________________________________________________________________________________________________________________________________________

| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes LCP Proximal Tibia Plates Line Extension |
| Classification: | 21 CFR 888.3030: Plate, Fixation, Bone, Non-spinal, metallic |
| Predicate Devices: | Synthes LCP Proximal Tibia Plates |
| Device Description: | The LCP Proximal Tibia Plates are contoured to match the<br>anatomy of the proximal tibia with a limited contact low profile<br>design. These are plates designed for either the right or left tibia in<br>a variety of shaft lengths. The plates have overall lengths ranging<br>from 298 mm to 370 mm and shaft holes ranging from 16 to 20<br>holes. |
| Intended Use: | The Synthes LCP Proximal Tibia System is intended for treatment<br>of nonunions, malunions, osteopenic bone, tibial osteotomies<br>(4.5mm plate only), and fractures of the proximal tibia, including<br>simple, comminuted, lateral wedge, depression, medial wedge,<br>bicondylar combination of lateral wedge and depression,<br>periprosthetic, and fractures with associated shaft fractures. |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K052390

Trade/Device Name: Synthes (USA) Proximal Tibia Plate Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 29, 2005 Received: August 30, 2005

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, 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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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 yours,

2

Mark N. Melkerson Acting 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):

K052390

Device Name:

2.0

Synthes (USA) Proximal Tibia Plate Line Extension

Indications for Use:

The Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, The Bylittes DOF Tronimal Ticli o (4.5mm plate only), and fractures of the proximal tibia, ostcopcure one, tronal ostoconnes ( "151122 p.depression, medial wedge, bicondylar combination moluding simple, comminuted, laterial bstractic, and fractures with associated shaft fractures.

X Prescription Use _ (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)

(Division Sign-OII)

Division of General, Restorative, and Neurological Devices

510(k) Number_Ko 5 23919