2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM

K101536 · Synthes (Usa), LLC · HRS · Sep 15, 2010 · Orthopedic

Device Facts

• Record ID: K101536
• Device Name: 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
• Applicant: Synthes (Usa), LLC
• Product Code: HRS · Orthopedic
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Device Story

The 2.7/3.5mm VA-LCP Anterior Clavicle Plate System is a metallic bone fixation device used by orthopedic surgeons to stabilize clavicle fractures, malunions, non-unions, and osteotomies. The system consists of pre-contoured, low-profile, limited-contact plates and variable angle (VA) locking screws. The plates feature a combination of dynamic compression (DCP) holes and VA locking holes, allowing surgeons to lock screws at trajectories diverging from the central axis of the plate hole. During surgery, the plate is applied to the clavicle to provide mechanical stability, facilitating bone healing. The system is designed to minimize vascular trauma through its limited-contact geometry. It utilizes standard cortex, locking cortex, and cancellous screws. The device provides structural support to the bone, aiding in the reduction and fixation of fractures.

Clinical Evidence

Bench testing only. Static compression ultimate load strength testing and engineering calculations were performed to compare the bending strength of the subject plate/screw construct against the predicate systems. Results confirmed the subject device has greater bending strength.

Technological Characteristics

Metallic bone fixation system consisting of machined alloy plates and variable angle (VA) locking screws. Features include pre-contoured geometry for clavicle anatomy, limited-contact design, and combination dynamic compression/threaded locking screw holes. Dimensions include variable lengths, shaft widths, and screw hole counts. Compatible with standard cortex, locking cortex, and cancellous screws.

Indications for Use

Indicated for fixation of clavicle fractures, malunions, non-unions, and osteotomies in adults, adolescents (12-18 years), and transitional adolescents (18-21 years), provided clavicular growth plates are fused or not crossed by the system.

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 3.5mm LCP Reconstruction Plate System (K000684)
• Synthes 3.5mm LCP Superior Anterior Clavicle Plate System (K073186)

Submission Summary (Full Text)

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## 510(k) Summary

| Date Prepared: | 09/15/2010<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | SEP 1 5 2010 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Lisa Graney<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | |
| Device Name: | 2.7/3.5mm VA-LCP Anterior Clavicle Plate System | |
| Classification: | Class II. §888.3030 - Single/multiple component metallic bone fixation<br>appliances and accessories | |
| Predicate Device: | Synthes 3.5mm LCP Reconstruction Plate System, K000684<br>Synthes 3.5mm LCP Superior Anterior Clavicle Plate System, K073186 | |
| Device Description: | The Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System<br>consists of plates of various lengths and variable angle screws that provide<br>the flexibility to lock screws in trajectories that can diverge from the<br>central axis of the plate hole. | |
| | The system features medial and lateral plates that are precontoured to<br>match the anatomy of the clavicle and a limited contact, low profile<br>design. The plate with lateral extension features Variable Angle (VA)<br>Locking holes and Dynamic Compression Plate (DCP) holes. The medial<br>plate features Dynamic Compression Plate (DCP) holes combined with<br>VA locking screw holes. | |
| Indications for Use: | The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is<br>indicated for fixation of fractures, malunions, non-unions, and osteotomies<br>of the clavicle in adults, and in both adolescents (12-18 years) and<br>transitional adolescents (18-21 years), in which the clavicular growth<br>plates have fused or in which the growth plates will not be crossed by the<br>plate system. | |

Premarket Notification 510(k): K101536 Synthes (USA) 2.7/3.5mm VA-LCP Anterior Clavicle Plate System

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Page 1 of 2

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#### Substantial Equivalence:

Comparison of design characteristics, test results, and engineering analysis supports substantial equivalence of the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle plate System to the predicate devices stated.

- . Indications for Use- are the same except that a pediatric indication has been added to the proposed plate.
- Technological Characteristics- The predicate systems and the proposed . systems:
- O Are machined metal plates made from the same alloys.
- Are pre-contoured for the clavicle. o

510(k) Summary (continued)

- Incorporate combination dynamic compression/threaded locking O screw holes.
- Have similar geometric dimensions- thickness, shaft width, overall 0 length, and number of screw holes.
- o Have limited contact designs for minimization of vascular trauma.
- Allow additional contouring. O
- Allow the same size cortex, locking cortex, and cancellous screws. 0
- . Testing/Engineering Analysis:
- Static Compression ultimate load strength testing showed that the 0 proposed plate system (plate/screw construct) has a much higher bending strength than that of the of the predicate plate systems.
- Engineering Calculations confirms that the bending strength of the o proposed plate system is greater than the bending strength of the predicate plate system.

Based on these results, the proposed 2.7/3.5 mm VA-LCP Anterior Clavicle plate system presents no new issues of safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, symbolizing the department's mission to protect and promote the health of Americans.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Synthes (USA) % Ms. Lisa Graney 1301 Goshen Parkway West Chester, Pennsylvania 19380

### SEP 1 5 2010

#### Re: K101536

Trade/Device Name: 2.7/3.5mm VA-LCP Anterior Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and appliances

Regulatory Class: II Product Code: HRS, HWC Dated: August 16, 2010 Received: August 16, 2010

Dear Ms. Graney:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Ms. Lisa Graney

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/ReportalProblem/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 yours,

faibare Buem

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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Indications for Use

K101536

# SEP 1 5 2010

510(k) Number (if known):

Device Name:

2.7/3.5mm VA-LCP Anterior Clavicle Plate System

Indications for Use:

The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Prescription Use X (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)

Souta for mxn
(Division Sign-off)

Division of Surgical, Othopedic, and Restorative Devices

510(k) Number K101536

Premarket Notification 510(k): Synthes (USA) 2.7/3.5mm VA-LCP Anterior Clavicle Plate System Page 1 of 1

CONFIDENTIAL

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