CMC MINI TIGHTROPE

K140328 · Arthrex, Inc. · HTN · Mar 10, 2014 · Orthopedic

Device Facts

• Record ID: K140328
• Device Name: CMC MINI TIGHTROPE
• Applicant: Arthrex, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Mar 10, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Device Story

The CMC Mini TightRope is a surgical fixation device consisting of two oblong stainless steel buttons connected by a single strand of #2 FiberWire suture. It functions as a fixation post or distribution bridge to stabilize the thumb metacarpal relative to the second metacarpal following trapezium excision. The device is used by orthopedic surgeons in a clinical/surgical setting to maintain suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty. By distributing suture tension, it provides mechanical stabilization, facilitating bone-to-bone or soft tissue-to-bone fixation, which supports the patient's recovery from CMC joint arthroplasty.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: stainless steel buttons, #2 FiberWire suture. Form factor: two-button and suture construct. Function: mechanical bone fixation/suture tension distribution. Sterilization: not specified.

Indications for Use

Indicated for patients undergoing Carpal Metacarpal (CMC) joint arthroplasty for osteoarthritis requiring trapezium excision; used as an adjunct for thumb metacarpal suspension and stabilization between the first and second metacarpals during hematoma distraction arthroplasty healing.

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

• Mini TightRope (K133275)

Submission Summary (Full Text)

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:

Arthrex Special. 510(K): ARTHREX CMC MINI TIGHTROPE

MAR 1 0 2014

| Date Summary Prepared | 06 FEBRUARY 2014 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/<br>Distributor/<br>Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Nancy Hoft<br>Regulatory Affairs Specialist<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext.71113<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | CMC Mini TightRope |
| Common Name | Button / Anchor / Suture |
| Product Code,<br>Classification Name, CFR | HTN - Single/multiple component metallic bone fixation appliances and<br>accessories -888.3030 |
| Predicate Device | Mini TightRope, K133275 |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain clearance for the<br>CMC Mini TightRope line extension. |
| Device Description | The Arthrex CMC Mini TightRope consists of two oblong stainless steel buttons<br>and a single strand of #2 FiberWire. |
| Intended Use | The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft<br>tissue-to-bone, is intended as a fixation post, distribution bridge, or for<br>distributing suture tension over areas of ligament or tendon repair. Specifically,<br>the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint<br>arthroplasty as an adjunct in the suspension of the thumb metacarpal during the<br>healing process of hematoma distraction arthroplasty by providing stabilization at<br>the base of the first and second metacarpal when the trapezium has been excised<br>due to osteoarthritis. |
| Substantial<br>Equivalence Summary | The Arthrex CMC Mini TightRope is substantially equivalent to the Arthrex<br>Implant System, Mini TightRope. Any differences between the CMC Mini<br>TightRope and this predicate are considered minor and do not raise questions<br>concerning safety and effectiveness. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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March 10, 2014

Arthrex, Inc. Ms. Nancy Hoft Regulatory Affairs Specialist 1370 Creekside Blvd. Naples, Florida 34108-1945

Re: K140328

Trade/Device Name: CMC Mini TightRope 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: February 6, 2014 Received: February 10, 2014

Dear Ms. Hoft:

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. Nancy Hoft

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/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 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,

# Lori A. Wiggins

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

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Arthrex SPECIAL 510(K): ARTHREX CMC MINI TIGHTROPE

## 2.5 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K140328

#### Device Name

### CMC Mini TightRope

Indications for Use (Describe)

The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft-tissue-tobone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Type of Use (Select one or both, as applicable)

Ø Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

# Please do not write below this line - continue on a separate page if needed.

国际游戏 | again | 亚游官网 | 亚洲官网 | 亚 FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

> Casey Li Hanley P. niof Orthopedic Devices Divisio

FORM FDA 3881 (9/13)

on 2 1013 64 147

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