SPEEDFIX SUTURE SYSTEM

K101437 · Arthrocare Corp. · MBI · Oct 29, 2010 · Orthopedic

Device Facts

• Record ID: K101437
• Device Name: SPEEDFIX SUTURE SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 29, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Device Story

SpeedFix Suture System is a bone anchor and instrumentation set for arthroscopic/orthopedic soft tissue-to-bone fixation. System includes implant, SpeedLock Drill, and SpeedLock Drill Guide. Used by surgeons in clinical/OR settings to secure tendons or ligaments to bone. Operates via mechanical insertion into bone substrate. Facilitates tissue reattachment, aiding healing and structural stability. Bench testing confirms performance against predicate.

Clinical Evidence

Bench testing only. In vitro testing performed in simulated human bone substrate, including static and cyclic fatigue testing, to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Bone anchor system for soft tissue fixation. Includes metallic bone fixation fasteners, drill, and drill guide. Materials are well-characterized and previously used in predicate devices. Mechanical fixation principle.

Indications for Use

Indicated for fixation of soft tissue to bone in orthopedic procedures including shoulder (Bankart, SLAP, rotator cuff, etc.), ankle (instability, Achilles repair), foot (hallux valgus), elbow (tennis elbow, biceps attachment), and knee (ligament/tendon repairs).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Opus® SpeedLock® Knotless Fixation Device (K090615)

Submission Summary (Full Text)

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K101437

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OCT 2 9 2010

510(K) SUMMARY ARTHROCARE CORPORATION SPEEDFIX SUTURE SYSTEM

## General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Establishment Registration No.: 2951580

Contact Person:

Laura N. Kasperowicz Sr. Manager, Regulatory Affairs

Date Prepared:

May 19, 2010

Device Description

Model Name: Generic/Common Name: Classification Name: Device Classification:

SpeedFix Suture System Bone Anchor, Fastener, Fixation, Soft Tissue Fastener, Fixation, Nondegradeable, Soft Tissue Class II per 21 CFR 888.3040, Product code: MBI

The following device-specific instrumentation is part of this submission:

| Model Name:<br>Generic/Common Name: | SpeedLock Drill<br>Bone Drill |
|-------------------------------------|-------------------------------|
| | |
| Generic/Common Name: | Bone Hole Locator |
| Model Name: | SpeedLock Drill Guide |
| Generic/Common Name: | Drill Guide |
| Predicate Devices | |
| t | <br>A AA10 |

Opus® SpeedLock® Knotless Fixation Device K090615 (June 3, 2010)

# Product Description

The SpeedFix Suture Implant is a bone anchor that facilitates the attachment of tissue to bone. The SpeedFix Suture System consists of an implant and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.

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#### K101437

# 510(K) SUMMARY

## Indications For Use

The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs: reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

### Substantial Equivalence

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The SpeedFix Suture Implant design and technology is substantially equivalent to the existing SpeedLock Knotless Fixation Device [K090615]. Side by side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors. The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing. The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices.

# Summary and Reason for 510k Notification

For the purpose of this premarket notification [510(k)], ArthroCare proposes a modification to an existing product. The proposed device, the SpeedFix Suture Implant, is substantially equivalent to the SpeedLock Knotless Fixation Device originally cleared under K090615.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written 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

ArthroCare Corporation % Ms. Laura Kasperowicz 680 Vaqueros Avenue Sunnyvale. California 94085-3523

OCT 2 9 2010

Re: K101437 Trade/Device Name: Speedfix Suture System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: September 30, 2010 Received: October 1, 2010

Dear Ms. Kasperowicz:

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. Iisting 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. Laura Kasperowicz

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Milburn

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

# OCT 2 9 2010

510(k) Number:

Device Name:

SpeedFix™ Suture System

K 101437

Indications for Use:

The SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Prescription Use (Part 21 CFR 801 Subpart D) X

AND/OR

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

NO

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Oputta for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101437