SYNTHES VA LCP ANKLE TRAUMA SYSTEM

K120854 · Synthes USA · HRS · Jun 18, 2012 · Orthopedic

Device Facts

• Record ID: K120854
• Device Name: SYNTHES VA LCP ANKLE TRAUMA SYSTEM
• Applicant: Synthes USA
• Product Code: HRS · Orthopedic
• Decision Date: Jun 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically, Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Device Story

System comprises metallic plates and screws for internal bone fixation in ankle trauma. Plates include Medial/Anteromedial Distal Tibia, Distal Tibia T/L, and Lateral Distal Fibula designs. System utilizes 2.7mm metaphyseal screws and 3.5mm Variable Angle (VA) Locking Screws; compatible with existing cortical and locking screws. Plates feature Combi holes allowing dynamic compression and locking. Used by orthopedic surgeons in clinical/OR settings to stabilize bone fragments; facilitates healing via rigid fixation. Benefits include improved stability in osteopenic bone and anatomical accommodation for various fracture patterns.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of engineering analysis, static strength testing, and fatigue strength testing to verify mechanical performance against predicate devices.

Technological Characteristics

Metallic bone fixation system; materials include stainless steel and titanium alloy (TAN). Features Combi holes for dynamic compression and locking. Includes various plate geometries (T, L, and anatomical distal tibia/fibula plates) and specialized screw configurations (2.7mm metaphyseal, 3.5mm VA locking). Offered in sterile and non-sterile configurations.

Indications for Use

Indicated for fixation of ankle fractures, osteotomies, nonunions, malunions, and replantations in adults and adolescents (12-21) with fused growth plates; specifically for distal tibia and fibula diaphyseal/metaphyseal regions; indicated for 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 4.5/3.5 LCP Metaphyseal Plates (K033805)
• Synthes 2.7/3.5 LCP Lateral Distal Fibula Plates (K083213 & K073460)
• Synthes One-Third Tubular Plates (K011335)
• 3.5mm Cortex Screws (K112583)
• 3.5 mm Locking Screws (K000684)
• Synthes 2.7mm VA Locking Screws (K100776)
• 4.5mm VA Curved Condylar Plate Set (K110354)
• 2.7/3.5mm VA-LCP Elbow System (K120070 and K120717)

Reference Devices

• 3.5mm Locking Screws (K043185)

Submission Summary (Full Text)

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# K12.0854

## JUN 1 8 2012

| 510K Summary | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes<br>Angela F. Lassandro<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes Variable Angle LCP Ankle Trauma System |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories.<br>Product Code: HRS, HWC |
| Predicate Device: | Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805)<br>Synthes 2.7/3.5 LCP Lateral Distal Fibula Plates (K083213 & K073460)<br>Synthes One-Third Tubular Plates (K011335)<br>3.5mm Cortex Screws (K112583)<br>3.5 mm Locking Screws (K000684)<br>Synthes 2.7mm VA Locking Screws (K100776)<br>4.5mm VA Curved Condylar Plate Set (K110354)<br>2.7/3.5mm VA-LCP Elbow System (K120070 and K120717) |
| Device<br>Description: | The Synthes Variable Angle LCP Ankle Trauma System contains plates that are<br>intended to treat fractures of the ankle, and includes multiple plate types to<br>accommodate different fracture patterns and patient anatomy. Two new screw<br>configurations are included in the Synthes Variable Angle LCP Ankle Trauma<br>System; 2.7mm metaphyseal screws and 3.5mm VA Locking Screws.<br>Specifically, the following plates and screws are included in the Synthes<br>Variable Angle LCP Ankle Trauma System:<br>• Medial and Anteromedial Distal Tibia Plates<br>• Distal Tibia T Plates and Distal Tibia L Plates<br>• Lateral Distal Fibula plate<br>• 2.7mm Metaphyseal Screws<br>• 3.5mm VA Locking Screws<br><br>All of the plates will be offered in both stainless steel and titanium alloy (TAN),<br>and in both sterile and non-sterile configurations. All of the plate configurations<br>(with the exception of the Distal Tibia T plate, which is symmetrical), will be<br>offered in left and right designs.<br>The system accepts existing cortical and locking screws (i.e. K000684 and<br>K043185) as well as new 3.5mm VA Locking Screws and 2.7mm Metaphyseal<br>Screws, and allows for both dynamic compression and locking through Combi<br>holes. |

Page 112

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Date Prepared: May 23, 2012

与10k Summary

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# K 120 854

| Intended Use: | The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation<br>of the ankle in adults and adolescents (12-21) in which the growth plates have<br>fused, and particularly in osteopenic bone. Specifically, Medial and Anteromedial Distal Tibia Plates are intended for fixation<br>of osteotomies, fractures, nonunions, malunions, and replantations of<br>bones and bone fragments of the diaphyseal and metaphyseal regions<br>of the distal tibia Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress<br>partial articular fractures and bone fragments of the distal tibia, and Lateral Distal Fibula Plates are intended for fixation of osteotomies,<br>fractures, nonunions, malunions, and replantations of bones and bone<br>fragments of the diaphyseal and metaphyseal regions of the distal<br>fibula. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence: | Both the subject Synthes VA-LCP Ankle Trauma System and predicate Synthes<br>Systems have similar indications, design characteristics, materials, and<br>performance characteristics. The subject system has been shown to be at least as<br>strong as the predicate systems through engineering analysis, static strength, and<br>fatigue strength testing. Similarly, the new screws have been shown to be<br>substantially equivalent to existing screws. |

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Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black.

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

## JUN 1 8 2012

Synthes % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380

#### Re: K120854

Trade/Device Name: Synthes Variable Angle LCP Ankle Trauma 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: May 23, 2012 Received: May 25, 2012

Dear Ms. Lassandro:

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 comply 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

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Page 2 – Ms. Angela F. Lassandro

device-related adverse events) (21 CFR 803); 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.

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.

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pto Rump Dr

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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Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person inside of a circle. The logo is also in black. There is a registered trademark symbol to the right of the word "SYNTHES".

### 4.0 - Indications for Use Statement

510(k) Number (if known):

120854

Device Name:

Synthes Variable Angle LCP Ankle Trauma System

Indications for Use:

The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,

- · Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- · Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
- · Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

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-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120854