APTUS(R) DISTAL HUMERUS SYSTEM

K112560 · Medartis AG · HRS · Dec 15, 2011 · Orthopedic

Device Facts

• Record ID: K112560
• Device Name: APTUS(R) DISTAL HUMERUS SYSTEM
• Applicant: Medartis AG
• Product Code: HRS · Orthopedic
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

APTUS® Distal Humerus System is indicated for fractures, osteotomies and non-unions of the distal humerus.

Device Story

APTUS Distal Humerus System consists of anatomically pre-contoured titanium locking plates, biconcave washers, and locking/non-locking titanium alloy screws. Used by orthopedic surgeons in clinical settings for internal bone fixation. Plates and washers are commercially pure titanium (ASTM F67); screws are titanium alloy (ASTM F136). Device provides structural support to stabilize distal humerus fractures, osteotomies, or non-unions, facilitating bone healing. Surgeon selects appropriate plate design (medial, lateral, or posterolateral) and length, securing them with TriLock locking, cortical, or lag screws. System functions as a mechanical fixation construct.

Clinical Evidence

Bench testing only. Performance data included engineering analysis and mechanical testing per ASTM F543, and fatigue testing of plate and screw constructs.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67) for plates/washers; titanium alloy (ASTM F136) for screws. Design: Anatomically pre-contoured locking plates in medial, lateral, and posterolateral designs. Fixation: TriLock locking, cortical, and lag screws. Mechanical testing: ASTM F543 and fatigue testing. Sterilization: Standard methods.

Indications for Use

Indicated for patients requiring fixation for fractures, osteotomies, and non-unions of the distal humerus.

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

• APTUS® Foot System (K091479)
• APTUS® Ulna Plates (K103332)
• Synthes (USA) 3.5 mm LCP Distal Humerus System (K033995)
• VariAx Elbow System (K101056)

Submission Summary (Full Text)

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510(k) Summary K112560

# DEC 1 5 2011
PTUS® Distal Humerus System

# 510(k) Summary

### Medartis AG

## APTUS® Distal Humerus System

#### K112560

#### November 14, 2011

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Medartis AG<br>Hochbergerstrasse 60E<br>CH-4057 Basel, Switzerland<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Ulrike Jehle<br>Regulatory Affairs Manager, Medartis AG |
| Representative/Consultant: | Kevin A. Thomas, PhD<br>Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130 USA<br>Telephone: [phone]<br>Fax: [phone] |

Email:

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | APTUS® Distal Humerus System |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Common Names: | Plate, fixation, bone; Screw, fixation, bone |
| Classification Names: | Single/multiple component metallic bone fixation appliances and accessories<br>Smooth or threaded metallic bone fixation fastener |
| Classification Regulations: | 21 CFR 888.3030, Class II<br>21 CFR 888.3040, Class II |
| Product Codes: | HRS, HWC |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |

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510(k) Summary K112560

#### INTENDED USE

APTUS® Distal Humerus System is indicated for fractures, osteotomies and non-unions of the distal humerus.

#### DEVICE DESCRIPTION

The APTUS Distal Humerus System consists of titanium locking plates, 2.5/2.8 biconcave washers, and locking and non-locking titanium alloy screws. APTUS Distal Humerus plates are anatomically pre-contoured and provided in six designs: medial plate left/right, lateral plate left/right and posterolateral plate left/right; each of the plates is available in two lengths. The plates are used with TriLock locking screws, cortical screws or lag screws. APTUS Distal Humerus plates and washers are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking, cortical, and lag screws are made of titanium alloy conforming to ASTM F136.

#### EQUIVALENCE TO MARKETED DEVICE

APTUS® Distal Humerus System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Medartis AG, APTUS® Foot System, cleared under K091479;

Medartis AG, APTUS® Ulna Plates, cleared under K103332;

Synthes (USA), Synthes (USA) 3.5 mm LCP Distal Humerus System, cleared under K033995; and

Howmedica Osteonics Corp., VariAx Elbow System, cleared under K101056.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics. The subject and predicate devices encompass the same range of physical dimensions, are packaged using the same materials, and are to be sterilized by the same methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

Performance data provided to demonstrate substantial equivalence included engineering analysis and mechanical testing according to ASTM F543, and fatigue testing of subject and predicate device plate and screw constructs.

Overall, the APTUS Distal Humerus System has the following similarities to the predicate devices:

- has the same intended use, .
- uses the same operating principles, ◆
- incorporates the same basic designs, .
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. .

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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 lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

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

Medartis AG % PaxMed International, LLC Mr. Kevin A Thomas 11234 El Camino Real, Suite 200 San Diego, California 92130

DEC 1 5 2011

Re: K112560

Trade/Device Name: APTUS® Distal Humerus System Regulation Number: 2 1 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 31, 2011 Received: November 1, 2011

Dear Mr. Thomas:

We have reviewed your Section 51.0(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 - Mr. Kevin A Thomas

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,

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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## Indications for Use

510(k) Number:

APTUS® Distal Humerus System Device Name:

Indications for Use:

APTUS® Distal Humerus System is indicated for fractures, osteotomies and non-unions of the distal humerus.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Z. N. S

(Division Sign-Off or MXM Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112560

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