ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM

K133835 · Arthrosurface, Inc. · HTN · Jul 3, 2014 · Orthopedic

Device Facts

• Record ID: K133835
• Device Name: ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
• Applicant: Arthrosurface, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Jul 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-2nd metatarsal (IM) angle.

Device Story

KISSloc™ Suture System is a non-resorbable bone fixation implant used for realignment and stabilization of skeletal deformities, specifically hallux valgus. The system comprises a small suture plate, an arrow plate, and a UHMWPE suture assembly. The suture loops around the arrow plate and passes through the suture plate holes to create the construct. The device is used by surgeons in a clinical setting to reduce the 1st metatarsal-2nd metatarsal (IM) angle. Ancillary insertion instruments are provided in a separate sterile disposable package. The implant provides mechanical stabilization to the bone, aiding in deformity correction.

Clinical Evidence

No clinical data was provided. Substantial equivalence was supported by non-clinical mechanical testing, including peak load to failure, cycle testing, displacement slippage, and Finite Element Analysis.

Technological Characteristics

System consists of a metallic suture plate, arrow plate, and UHMWPE suture assembly. Materials include Titanium and UHMWPE. The device is a single/multiple component metallic bone fixation appliance. Provided sterile.

Indications for Use

Indicated for patients requiring reconstruction or correction of hallux valgus deformity via reduction of the 1st metatarsal-2nd metatarsal (IM) angle.

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

• Arthrex Mini TightRope (K090107)
• Arthrex Mini TightRope Repair Kit (K061925)

Submission Summary (Full Text)

{0}------------------------------------------------

## JUL 0 3 2014

| Section 5 510(k) Summary | |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Dawn Wilson<br>VP, Quality & Regulatory |
| Date of Preparation: | November 27, 2013 |
| Trade Name: | KISSloc™ Suture System |
| Common Name: | Plate & Suture System |
| Device: | Single/multiple component metallic bone fixation<br>appliances and accessories |
| Classification Regulation:<br>Device Class:<br>Review Panel:<br>Product Code: | Regulation Number 888.3030<br>Class II<br>Orthopedic<br>HTN |

### Device Intended Use

Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-2nd metatarsal (IM) angle.

# Device Description

The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for realignment and stabilization of an underlying skeletal deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.

{1}------------------------------------------------

#### Substantial Equivalency:

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

| · Arthrex Mini TightRope | K090107 |
|-------------------------------------|---------|
| · Arthrex Mini TightRope Repair Kit | K061925 |

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

- Intended for treatment of Hallux Valgus deformity. .
- . Similar device designs
- Same Titanium and UHMWPE implant materials .

In support of this submission, non-clinical mechanical tests and engineering evaluations were performed on the subject device and comparable predicate:

- . Peak load to failure (N)
- Number of cycles completed prior to failure .
- Displacement slippage per cycle interval .
- Finite Element Analysis .
- Clinical Evaluations .

The test reports demonstrate the Arthrosurface KISSloc™ device was equivalent or outperformed the Arthrex predicate device for the non-clincial mechanical tests conducted.

No clinical data was provided in support of this substantial equivalency.

The results have demonstrated the safety and effectiveness of the KISSloc™ Suture System along with substantial equivalence to the predicate devices. Minor differences in device design and technique were determined not to be critical to the intended use of the device when used as labeled.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WO66-G609 Silver Spring, MI) 20993-0002

Arthrosurface. Incorporated Ms. Dawn Wilson Vice President, Quality and Regulatory 28 Forge Parkway Franklin. Massachusetts 02038

Re: K133835

Trade/Device Name: KISSLocTM Suture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: May 30, 2014 Received: June 2, 2014

July 3, 2014

Dear Dawn 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

{3}------------------------------------------------

Page 2 - Ms. Dawn Wilson

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark Melkerson Director, Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### Section 4 Indications for Use Statement

510(k) Number (if known): K133835

Device Name: KISSloc™ Suture System

#### Indications for Use:

Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 186 metatarsal-2nd metatarsal (IM) angle.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Page 1 of 1

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices