PINIT SMALL BONE FUSION SYSTEM

K140617 · Arthrosurface, Inc. · HRS · Apr 25, 2014 · Orthopedic

Device Facts

• Record ID: K140617
• Device Name: PINIT SMALL BONE FUSION SYSTEM
• Applicant: Arthrosurface, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Device Story

Pinit™ Small Bone Fusion System consists of 2-hole stainless steel bone plates and 2.0 mm/2.7 mm diameter bone screws. Plates feature pre-assembled suture loops for bone segment compression; screws include snap-off feature for standalone fixation or plate use. System used by orthopedic surgeons in clinical settings for small bone procedures. Modification adds plates with varying thicknesses to existing design profile. Device provides mechanical stabilization and compression to facilitate bone healing.

Clinical Evidence

Bench testing only. Testing included bending moment/flexural strength testing and engineering analyses/calculations using bending theory to demonstrate equivalence to predicate devices.

Technological Characteristics

Implant grade stainless steel bone plates and screws. Plates are 2-hole with varying lengths and thicknesses. Screws are 2.0 mm and 2.7 mm diameter with snap-off feature. Mechanical fixation via plates and screws. Sterilized using same processes as predicate.

Indications for Use

Indicated for fracture fixation, osteotomies, reconstruction, revision surgery, and arthrodesis of small bones in upper and lower extremities.

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

• CheckMate™ Small Bone Fusion System (K122334)
• Aptus® 1.5 TriLock (K102537)
• Arthrex Small Fragment Plates and Screws (K040907)

Submission Summary (Full Text)

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# K140617

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#### Section 5 510(k) Summary

# Pinit™ Small Bone Fusion System Special 510(k): Device Modification

510(k) Owner:

Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 Tel: [phone] Fax: [phone]

Contact:

Dawn Wilson VP, Quality & Regulatory 508.520.3003 Tel: [phone] Fax: [e-mail]

| Establishment Registration<br>Number: | 3004154314 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | March 25, 2014 |
| Confidentiality: | Reference Section 3 |
| Proprietary Name: | Pinit ^TM Small Bone Fusion System |
| Common Name: | Bone Plates and Screws |
| Regulation Description: | Single/multiple component metallic bone<br>fixation appliances and accessories.<br>Smooth or threaded metallic bone fixation<br>fastener |
| Regulation Number: | 888.3030<br>888.3040 |

Device Class:

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Review Panel:

Orthopedic

Product Code:

HRS: HWC

#### Intended Use

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

### Device Description

The Pinit™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options and two thickness options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture loop intended to provide a traction force required to achieve compression between bone seaments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.

The only modification made in this submission was the addition of bone plates having the same design profile with a different thickness. Also, the Trade/Proprietary Name was changed from CheckMate™ to Pinit™.

#### Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Pinit™ Small Bone Fusion System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:

CheckMate™ Small Bone Fusion System (K122334, Cleared on 11/28/2012) Aptus® 1.5 TriLock (K102537, Cleared on 12/10/2010) Arthrex Small Fragment Plates and Screws (K040907, Cleared on 07/01/2004)

The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K122334).

- Have the same Indications for Use, .

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- Use the same operating principle, .
- Have the same design profile, .
- Manufactured using the same material, .
- Have the same shelf life, .
- Are packaged and sterilized using the same materials and processes. .

In support of this submission, the following non-clinical tests and analysis have been performed for the Subject Device:

- Bending Moment/Flexural Strength Testing .
- . Engineering Analyses/Calculations using Bending Theory

The results have demonstrated that the Arthrosurface Pinit™ Implants are substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes.

Public Health Service

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

April 25, 2014

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

Re: K140617

Trade/Device Name: Pinit™ Small Bone Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component bone fixation appliances and accessories Regulatory Class: Class 11 Product Code: HRS, HWC Dated: March 25, 2014 Received: March 26, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Ms. Dawn J. Wilson

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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

# Ronald P. Jean -S for

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

Enclosure

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# Section 4 Indications for Use Statement 1 - 1 - 1 - 1 - 1 -

510(k) Number (if known): _ K140617

Device Name: Pinit™ Small Bone Fusion System

#### Indications for Use:

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Prescription Use V (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 OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Limin Sun-S 2014.04.25 14:45:31 -04'00'

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140617

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