SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES

K092812 · Synthes (Usa) · HRS · May 11, 2010 · Orthopedic

Device Facts

• Record ID: K092812
• Device Name: SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: May 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Device Story

Low-profile, pre-contoured metallic bone plates designed for distal tibia fixation. Plates feature specific left and right configurations to match anatomical contours. Used by orthopedic surgeons in clinical settings to stabilize bone fractures, osteotomies, or non-unions. Provides mechanical support to bone segments, particularly beneficial in osteopenic bone where traditional fixation may be less stable. Device is implanted surgically to facilitate healing.

Clinical Evidence

No clinical data; substantial equivalence supported by bench testing (geometrical bending strength analysis, static bend testing, dynamic fatigue testing) and a review of published clinical literature.

Technological Characteristics

Metallic bone fixation plates; low-profile, pre-contoured design; stainless steel construction; specific left/right versions; locking compression plate (LCP) technology.

Indications for Use

Indicated for patients with fractures, osteotomies, or non-unions of the distal tibia, particularly those with 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 3.5mm LCP Distal Tibia T Plates (K080522)
• Synthes LCP Distal Tibia Plates (K013248)
• Synthes Pilon Plate (K020602)
• Depuy Orthopaedics, Inc. Anterolateral and Medial Locking Plating System (K072832)

Submission Summary (Full Text)

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MAY 1 1 2010

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## K092812_

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date Prepared: | May 5, 2010 |
| | Sponsor: | Synthes (USA)<br>Karl J. Nittinger<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| | Device Name: | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia<br>Plates |
| | Classification: | Class II, §888.3030 - Single / multiple component metallic bone<br>fixation appliance and accessories. |
| | Predicate Device: | Synthes 3.5mm LCP Distal Tibia T Plates (K080522)<br>Synthes LCP Distal Tibia Plates (K013248)<br>Synthes Pilon Plate (K020602)<br>Depuy Orthopaedics, Inc. Anterolateral and Medial Locking Plating<br>System (K072832) |
| | Device Description: | The Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates<br>are low-profile plates with a pre-contoured shape designed to<br>conform to the distal tibia. The plates are available in stainless steel<br>and feature specific versions for the right and left tibia. |
| | Indications for<br>Use: | Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are<br>indicated for fractures, osteotomies, and non-unions of the distal<br>tibia, especially in osteopenic bone. |
| | Substantial<br>Equivalence: | Information presented supports the substantial equivalence of the<br>Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates to<br>the predicate devices. The proposed plate has the same indications<br>for use, incorporates the same fundamental product technology and<br>is composed of the same material.<br>Preclinical bench testing and analyses were conducted in support of<br>a determination of substantial equivalence including: |
| | | • Geometrical bending strength analysis. |
| | | • Static bend testing. |
| | | • Dynamic fatigue testing. |
| | | • Published clinical literature review |

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

Synthes (USA) % Mr. Karl Nittinger Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380

MAY 1 1 2010

Re: K092812

Trade/Device Name: Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single / multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS Dated: April 15, 2010 Received: April 29, 2010

Dear Mr. Nittinger:

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

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Page 2 - Mr. Karl Nittinger

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 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/CentersOflices/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 yours,

Ckalbay Buelmp

Mark N. Melkerso 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): | K092812 |
|---------------------------|-------------------------------------------------------------------|
| Device Name: | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates |

Indications for Use:

Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

| Prescription Use<br>(Per 21 CFR 801.109) | X AND/OR Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
|------------------------------------------|---------------------------------------------------------|
|------------------------------------------|---------------------------------------------------------|

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonitu for mxm
(Division Sign-off)

(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092812