CMC CABLE FIX

K111032 · Instratek, Inc. · HTN · Aug 31, 2011 · Orthopedic

Device Facts

• Record ID: K111032
• Device Name: CMC CABLE FIX
• Applicant: Instratek, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Aug 31, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Instratek CMC Cable Fix is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable Fix is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability.

Device Story

CMC Cable FIX is a suture button implant system for thumb metacarpal stabilization. Components include Ti-6Al-4v plates (2-hole round and 2-hole oblong with break-away guide wire) and Ultra High Molecular Weight Polyethylene #2 suture. Accessories include 17-4 stainless steel cannulated drill bit, 316L stainless steel K-wire, and PTFE tubing suture passer. Used by surgeons in clinical/OR settings during biologic ligament reconstruction procedures. Implanted to stabilize the thumb metacarpal after trapezium resection; acts as an adjunct to healing for CMC arthritis and instability. Provides mechanical support to the reconstructed ligament.

Clinical Evidence

Bench testing only. Comparative suture tensile force (N) vs. displacement (mm) was performed to demonstrate substantial equivalence.

Technological Characteristics

Implant materials: Ti-6Al-4v (plates), Ultra High Molecular Weight Polyethylene (suture). Accessories: 17-4 stainless steel (drill bit), 316L stainless steel (K-wire), PTFE (suture passer). Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for patients requiring thumb metacarpal stabilization following trapezium removal or partial resection, specifically as an adjunct to biologic ligament reconstruction for carpometacarpal (CMC) arthritis and instability.

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™ Repair Kit (K090107)
• Michelangelo Bunion System (K091763)

Submission Summary (Full Text)

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Traditional 510(k)

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KIII032

## SECTION 5. 510(K) SUMMARY

| Submission Correspondent<br>and Owner | Instratek, Inc.<br>4141 Directors Row, Suite H<br>Houston, TX 77092 | AUG 3 1 2011 |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Mr. Jeff Seavey<br>Vice President | |
| Date summary prepared:<br>Device trade name:<br>Device common name: | August 15, 2011<br>CMC Cable FIX<br>Button/Suture | |
| Device classification name: | Washer, Bolt Nut, HTN at 21 CFR 888.3030 | |
| Legally marketed device to<br>which the device is<br>substantially equivalent: | Arthrex Mini TightRope™ Repair Kit, K090107<br>Michelangelo Bunion System, K091763 (material only) | |
| Description of the device: | The Instratek CMC Cable FIX is a suture button implant designed<br>to stabilize the thumb metacarpal following removal or partial<br>resection of the trapezium. The CMC Cable FIX is an adjunct in the<br>healing process when used in conjunction with a biologic<br>reconstruction of the ligament at the base of the thumb metacarpal<br>for treatment of carpometacarpal (CMC) arthritis and instability.<br>The implanted device consists of three (3) components:<br>Plate - 2-hole round - Ti-6Al-4v Plate - 2-hole oblong w/break away guide wire - Ti-6AL-4v #2 Suture - Ultra High Molecular Weight Polyethylene There are 3 accessories required to implant the device:<br>Cannulated Drill Bit - 17-4 Stainless Steel K-wire - 316L Stainless Steel Suture Passer - PTFE tubing | |
| Intended use of the device: | The Instratek CMC Cable FIX is a suture button implant designed<br>to stabilize the thumb metacarpal following removal or partial<br>resection of the trapezium. The CMC Cable FIX is an adjunct in the<br>healing process when used in conjunction with a biologic<br>reconstruction of the ligament at the base of the thumb metacarpal<br>for treatment of carpometacarpal (CMC) arthritis and instability. | |
| Technological<br>characteristics: | The technological characteristics between the predicate and<br>proposed devices are the same. | |
| Testing: | The following testing was performed to demonstrate substantial<br>equivalence.<br>Comparative Suture Tensile Force (N) vs. Displacement<br>(mm). | |
| Conclusions: | There are no significant differences between the proposed and<br>predicate device; therefore, the proposed device does not raise any<br>questions regarding safety and effectiveness.<br>The CMC Cable FIX, as designed, is as safe and effective as the<br>predicate devices. Comparisons have been made to a legally<br>marketed predicate device, and the device is determined to be<br>substantially equivalent to the referenced predicate device currently<br>on the market. | |

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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 features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Instratek, Inc. % Mr. Jeff Scavey 4141 Director's Row Suite H Houston. Texas 77092

AUG 3 1 2011

Re: K111032

Trade/Device Name: Instratek CMC Cable FIX Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: August 18, 2011 Received: August 18, 2011

Dear Mr. Seavev:

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

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Page 2 - Mr. Jeff Scavey

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm1.15809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

signature

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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## SECTION 4. INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K111032 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CMC Cable Fix |
| Indications for Use: | The Instratek CMC Cable Fix is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable Fix is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability. |

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Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices

16111032

510(k) Number _

Instratek, Inc