SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM

K120689 · Synthes (USA) Products, LLC · HRS · Jun 4, 2012 · Orthopedic

Device Facts

• Record ID: K120689
• Device Name: SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
• Applicant: Synthes (USA) Products, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Jun 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies and osteopenic bone.

Device Story

System consists of pre-contoured metallic bone fixation plates and variable angle screws for proximal tibia fracture treatment. Variable angle screws allow up to 15-degree angulation from normal trajectory before locking to plate. Designed for use with percutaneous instrumentation for minimally invasive surgical techniques. Operated by orthopedic surgeons in clinical/OR settings. Provides stable internal fixation to facilitate bone healing. Benefits include anatomical fit and flexibility in screw placement for complex fracture patterns.

Clinical Evidence

Bench testing only. Mechanical evaluation included static and dynamic construct testing to assess fatigue strength and bending moment, confirming performance comparable to predicate devices.

Technological Characteristics

Metallic bone fixation plates and screws. Features variable angle locking mechanism allowing 15-degree screw angulation. Pre-contoured design for proximal tibia. Compatible with percutaneous instrumentation for minimally invasive application.

Indications for Use

Indicated for adults and adolescents with fused growth plates requiring treatment for proximal tibia fractures (simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, periprosthetic, shaft fractures), nonunions, malunions, tibial osteotomies, and 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 4.5mm LCP Proximal Tibia Plate (K011978)
• Synthes LCP Proximal Tibia Plate (K052390)
• Synthes Large Fragment Dynamic Compression Locking (DCL) System (K000682)
• OrthoPediatrics PediLoc™ Locking Plate System (K083286)

Submission Summary (Full Text)

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K120689

JUN - 4 2012

#### 3.0 510(k) Summary

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| Sponsor: | Synthes<br>Thomas N. Shéa<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes 3.5 mm VA-LCP Proximal Tibia Plate System |
| Classification: | Product Code - HRS/HWC, Plate, Fixation, Bone, Class II,<br>§888.3030 - (Single/multiple component metallic bone fixation<br>appliances and accessories.) |
| Predicate Devices: | Synthes 4.5mm LCP Proximal Tibia Plate K011978<br>Synthes LCP Proximal Tibia Plate K052390<br>Synthes Large Fragment Dynamic Compression Locking (DCL)<br>System K000682<br>OrthoPediatrics PediLoc™ Locking Plate System K083286 |
| Device Description: | The Synthes 3.5 mm VA-LCP Proximal Tibia Plate System consists<br>of pre-contoured bone fixation plates intended for the treatment of<br>fractures of the proximal tibia. Variable angle screws can be angled<br>up to 15 degrees from the normal trajectory prior to locking the screw<br>to the plate. Percutaneous instrumentation will allow the variable<br>angle plates and screws to be applied through minimally invasive<br>techniques. |
| Intended Use: | The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in<br>which the growth plates have fused including: simple, comminuted,<br>lateral wedge, depression, medial wedge, bicondylar combination of<br>lateral wedge and depression, periprosthetic, and fractures with<br>associated shaft fractures. Plates can also be used for treatment of<br>nonunions, malunions, tibial osteotomies and osteopenic bone. |
| Substantial<br>Equivalence: · | Information presented supports substantial equivalence of the Synthes<br>3.5 mm VA-LCP Proximal Tibia Plate System to the predicate<br>devices, Synthes 4.5mm LCP Proximal Tibia Plate K011978. Synthes<br>Large Fragment Dynamic Compression Locking (DCL) System<br>K000682, and Orthopediatrics PediLoc Locking Plate System<br>K083286. The proposed tibia plates have the same indications for<br>use, are similar in shape/design and incorporate the same fundamental<br>technology.<br>Static and dynamic construct testing was conducted on the proposed<br>plates and screws in order to demonstrate comparable mechanical<br>performance to the predicate. The mechanical testing was designed to<br>assess the fatigue strength and bending moment of the subject device. |

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K120689

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The results of the mechanical evaluation confirm that the subject . device is substantially equivalent to the predicate.

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Premarket Notification 510(k) Synthes 3.5 mm VA-LCP Proximal Tibia Plate System

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three talons, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Synthes (USA) Products LLC % Mr. Thomas N. Shea Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

JUN - 4 2012

## Re: K120689

Trade/Device Name: Synthes 3.5 mm VA-LCP Proximal Tibia Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II

Product Code: HRS. HWC Dated: March 2, 2012 Received: March 6, 2012

## Dear Mr. Shea:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Mr. Thomas N. Shea

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR. Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0

Indications for Use

510(k) Number (if known): (120689

Device Name:

## Synthes 3,5 mm VA-LCP Proximal Tibia Plate System

Indications for Use:

The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies and i osteopenic bone.

Prescription Use · AND/OR X (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RRRuch for

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K 120689

Premarket Notification 510(k) Synthes 3.5 mm VA-LCP Proximal Tibia Plate System