SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR

K130196 · Arthrocare Corp. · MBI · Feb 27, 2013 · Orthopedic

Device Facts

• Record ID: K130196
• Device Name: SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
• Applicant: Arthrocare Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Feb 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpeedLock Knotless Fixation 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

SpeedLock Knotless Fixation System; bone anchor with inserter handle for arthroscopic/orthopedic soft tissue-to-bone fixation. Eliminates need for surgical knots. Consists of 3.4 mm PEEK bone anchor and disposable preloaded inserter. Used by surgeons in OR. Modifications include distal window geometry adjustment and internal crossbar flat surface for plug seating. Device implanted into bone; provides mechanical fixation. Benefits patient by simplifying soft tissue attachment procedures.

Clinical Evidence

No clinical or animal data included. Bench testing only; design verification and mechanical pull-out strength testing performed in simulated bone substrate.

Technological Characteristics

3.4 mm PEEK bone anchor; disposable inserter handle. Mechanical fixation principle. Single-use. Sterilized. No software or electronic components.

Indications for Use

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

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

• SpeedLock Knotless Fixation System (K111044)

Submission Summary (Full Text)

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## K130196

# 510(k) Summary

FEB 2 7 2013

### ArthroCare® Corporation SpeedLock® Knotless Fixation System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### General Information

| Submitter Name: | ArthroCare Corporation |
|-----------------|----------------------------------------------------|
| Address: | 7000 West William Cannon Drive<br>Austin, TX 78735 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Cheryl Frederick<br>Director, Regulatory Affairs |
| Date Prepared: | January 25, 2013 |

#### Device Name

| Proprietary: | SpeedLock® Knotless Fixation System |
|-----------------|----------------------------------------------|
| Common: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification: | Class II |
| Product Code: | MBI |
| CFR Section: | 21 CFR 888.3040 |

#### Predicate Device

This 510(k) relates to a modification to the SpeedLock Knotless Fixation System cleared under K111044 on August 9, 2011.

#### Description

The SpeedLock Knotless Fixation System is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of soft tissue to bone.

The SpeedLock consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter, which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized. Both the anchor and inserter are designed for single use only.

The SpeedLock System also includes associated instruments for implanting the anchor into bone.

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## K130196

The design modifications include aligning the shape and size of the windows at the distal end of the anchor and adding a flat surface to the internal crossbar against which the anchor plug may rest once deployed. The modifications do not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the devices cleared indications for use.

#### Intended Use/Indications For Use

The SpeedLock Knotless Fixation 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

#### Non-Clinical Data

Design Verification testing was performed to demonstrate that the modifications to the cleared SpeedLock Knotless Fixation System do not alter the device's intended use or performance. Insertion strength and pull-out strength testing in a simulated bone substrate was also conducted.

The test results demonstrate that the modified SpeedLock Knotless Fixation System meets its design, performance, and safety specifications.

#### Clinical Data

No clinical or animal data are included in this submission.

#### Summary

All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling.

Since the modified device's intended use and technological characteristics are the same as those for the previously cleared device, we do not believe that the modification to the SpeedLock Knotless Fixation System raises any new questions of safety or effectiveness.

ii

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

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

#### February 27, 2013

ArthroCare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735

Re: K130196

Trade/Device Name: SpeedLock® Knotless Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 25, 2013 Received: January 28, 2013

Dear Ms. Frederick:

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

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#### Page 2 - Ms. Cheryl Frederick

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH0ffices/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.

# Erin Neith

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

Enclosure

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# Indications for Use

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: SpeedLock® Knotless Fixation System

#### Indications for Use:

The SpeedLock Knotless Fixation 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 X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey E. Hanley, Ph.D.
Division of Orthopaedic Devices

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