CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM

K113762 · Arthrosurface, Inc. · HRS · Feb 6, 2012 · Orthopedic

Device Facts

• Record ID: K113762
• Device Name: CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
• Applicant: Arthrosurface, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 1st MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.

Device Story

CheckMate™ MTP Arthrodesis System consists of anatomically contoured bone plates and locking/non-locking/interfragmentary screws. Used by orthopedic surgeons in clinical settings for surgical fusion (arthrodesis) of the 1st MTP joint. Device provides mechanical stabilization and fixation of bone segments during healing. Benefits include structural support for fusion, osteotomy, or revision procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence supported by comparative static and dynamic four-point bending tests and dimensional analyses.

Technological Characteristics

System comprises metallic bone plates and screws. Features include left/right anatomical configurations and locking/non-locking/interfragmentary screw options. Mechanical fixation device.

Indications for Use

Indicated for stabilization and fixation of the 1st MTP joint in the foot for patients requiring fusion, osteotomy, nonunion, malunion, or revision surgery.

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

• DePuy ALPS Small Bone Locked Plating System (K101240)
• Arthrex Low Profile Plate and Screw System (K052614)
• Synthes 2.4 mm/2.7 mm Variable Angle (VA)-LCP Forefoot/Midfoot System (K100776)

Submission Summary (Full Text)

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# 12 K113762 .

#### Section 5 510(k) Summary

| 510(k) Owner: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038 |
|----------------------------|---------------------------------------------------------------|
| Tel: | 508.520.3003 |
| Fax: | 508.528.4604 |
| Contact: | Dawn Wilson<br>VP, Quality & Regulatory |
| Date of Preparation: | December 16, 2011 |
| Trade Name: | CheckMate™ Metatarso-Phalangeal (MTP)<br>Arthrodesis System |
| Common Name: | Arthrosurface Toe Plate System |
| Device: | Plate, fixation, bone |
| Classification Regulation: | Regulation Number 888.3030 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HRS |

### Device Intended Use

The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 155 MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.

### Device Description

The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System consists of anatomically contoured bone plates and screws which are intended to be used for surgical fusion (arthrodesis) of the 1st MTP joint. The plate is available in both left and right configurations. Locking, non-locking and interfragmentary screws are included as part of the system.

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## Substantial Equivalency:

The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:

- DePuy ALPS Small Bone Locked Plating System K101240 t
- Arthrex Low Profile Plate and Screw System K052614 .
- Synthes 2.4 mm/2.7 mm Variable Angle (VA)-LCP K100776 . Forefoot/Midfoot System

Comparative static and dynamic four point bending test results, along with comparative dimensional analyses were used to support equivalence to predicate devices.

The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

FEB - 6 2012

Arthrosurface, Inc. % Ms. Dawn Wilson 28 Forge Parkway Franklin, MA 02038

Re: K113762

Trade/Device Name: CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: December 16, 2011 Received: December 21, 2011

Dear Ms. Wilson:

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. Dawn Wilson

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,

for D.T.A.
Deplies

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 Section 4

510(k) Number (if known): K113762

Device Name:

CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System

#### Indications for Use:

The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 1st MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.

Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ਿੰਡ

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

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510(k) Number K113762