SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)

K120717 · Synthes USA · HRS · May 8, 2012 · Orthopedic

Device Facts

• Record ID: K120717
• Device Name: SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
• Applicant: Synthes USA
• Product Code: HRS · Orthopedic
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, · Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. · Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

Device Story

System consists of medial and posterolateral distal humerus plates used in 90° construct; compatible with existing screws and new 2.7mm Metaphyseal Screws. Used by orthopedic surgeons in clinical/OR settings for bone fixation. Provides mechanical stabilization of fractures, osteotomies, malunions, and non-unions to facilitate healing.

Clinical Evidence

Bench testing only. Static and fatigue strength testing and engineering analysis performed to compare subject device to predicates.

Technological Characteristics

Metallic bone fixation plates and screws. Variable angle locking mechanism. Compatible with 2.7mm Metaphyseal Screws. Mechanical performance validated via static and fatigue strength testing.

Indications for Use

Indicated for fixation of distal humerus, olecranon, and ulna fractures, osteotomies, malunions, and non-unions in adults and adolescents (12-21 years) with fused growth plates.

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 Elbow System (K033995)
• Synthes Small Fragment System (K000684)
• Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot /Midfoot System (K100776)
• Synthes 2.7/3.5mm VA-LCP Elbow System (K120070)

Submission Summary (Full Text)

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## 5.0 - 510(k) Summary

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Date Prepared: April 6, 2012

| Sponsor: | Synthes<br>Angela F. Lassandro<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Variable Angle LCP Elbow System (Medial and Posterolateral Distal<br>Humerus Plates) |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories.<br>Product Code: HRS, HWC |
| Predicate Device: | Synthes 3.5mm LCP Elbow System (K033995)<br>Synthes Small Fragment System (K000684)<br>Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot /Midfoot System (K100776)<br>Synthes 2.7/3.5mm VA-LCP Elbow System (K120070) |
| Device Description: | The Synthes Variable Angle LCP Elbow System contains posterolateral and<br>medial plates intended to treat fractures of the distal humerus. The plates are<br>used together in a two-plate, 90° construct and accept existing screws. New<br>2.7mm Metaphyseal Screws are also compatible with the System. |
| Intended Use: | The Synthes Variable Angle LCP Elbow System is intended for fixation<br>of fractures of the distal humerus, olecranon and ulna in adults and<br>adolescents (12-21) in which the growth plates have fused. Specifically,<br>· Distal humerus plates are indicated for intra-articular fractures,<br>comminuted supracondylar fractures, osteotomies, malunions and<br>non-unions of the distal humerus.<br>· Olecranon and Proximal ulna plates are indicated for fractures,<br>osteotomies, malunions and non-unions of the olecranon and<br>proximal ulna. |
| Substantial Equivalence: | Both the subject Synthes Variable Angle Elbow System (Medial and<br>Posterolateral Distal Humerus Plates) and predicate Synthes 3.5mm LCP Elbow<br>System (K033995) and Synthes Small Fragment System (K000684) have similar<br>indications, design characteristics, materials, and performance characteristics.<br>Static and fatigue strength testing, as well as an engineering analysis, was<br>completed for Medial and Posterolateral Distal Humerus Plates, demonstrating<br>equal to or greater strength in comparison to the predicate devices and |

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constructs. Additionally, mechanical testing for the 2.7mm Metaphyseal Screws demonstrated substantial equivalence in comparison to the existing 2.7mm VA Locking Screws (K100776).

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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 stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAY - 8 2012

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

Re: K120717

Trade/Device Name: Synthes Variable Angle LCP Elbow System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS, HWC Dated: March 5, 2012 Received: March 12, 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

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## Page 2 - Ms. Angela F. Lassandro

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 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 yours,

Ernst Klett

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 Statement

510(k) Number (if known):

K120717

Synthes Variable Angle LCP Elbow System Device Name:

Indications for Use:

The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,

· Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.

· Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

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)

Andist

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

510(k) Number k120217