SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE

K111044 · ArthroCare Corporation · MBI · Aug 9, 2011 · Orthopedic

Device Facts

• Record ID: K111044
• Device Name: SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
• Applicant: ArthroCare Corporation
• Product Code: MBI · Orthopedic
• Decision Date: Aug 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpeedLock Knotless Fixation Device 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

Device Story

SpeedLock Knotless Fixation Device is a bone anchor system with an inserter handle used in arthroscopic and orthopedic surgeries. The device facilitates the fixation of soft tissue to bone. It is operated by surgeons in a clinical/OR setting. The system includes associated accessories such as bone drills and obturators for bone hole location. The device is used to secure tendons or ligaments to bone, aiding in tissue repair and reconstruction. It provides mechanical fixation to support healing.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bone anchor system with inserter handle. Materials are well-characterized and consistent with predicate devices. Mechanical fixation principle. Class II device per 21 CFR 888.3040 (Product code: MBI).

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, midfoot), foot (hallux valgus), elbow (tennis elbow, biceps tendon), 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

• Opus® SpeedLock® Knotless Fixation Device (K090615)

Submission Summary (Full Text)

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K111044 #1/2

### 510(K) SUMMARY

AUG - 9 2011

ARTHROCARE CORPORATION SPEEDLOCK KNOTLESS FIXATION SYSTEM

#### General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Establishment Registration No .:

Contact Person:

2951580 Laura N. Kasperowicz

Sr. Manager, Regulatory Affairs

Date Prepared:

April 14, 2011

Device Description

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

Model Name: Generic/Common Name:

Model Name: Generic/Common Name:

Model Name: Generic/Common Name:

Model Name: Generic/Common Name:

Model Name: Generic/Common Name:

Predicate Devices Opus® SpeedLock® Knotless Fixation Device SpeedLock Knotless Fixation Device Bone Anchor, Fastener, Fixation, Soft Tissue Fastener, Fixation, Nondegradeable, Soft Tissue Class II per 21 CFR 888.3040, Product code: MBI

Drill, 3.0 mm Bone Drill

PathFinder® Obturator Bone Hole Locator

Sharp-Tipped Obturator Bone Hole Locator

Drill Guide, 3.5mm High Visibility Drill Guide

Drill Guide, 3.5mm Low Profile Drill Guide

K090615 (June 3, 2010)

#### Product Description

The SpeedLock Knotless Fixation Device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

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K111044 **

## 510(K) SUMMARY

#### Indications For Use

The SpeedLock Knotless Fixation Device 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 SpeedLock Knotless Fixation device 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 differences between the SpeedLock 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

The purpose of this 510(k) is to notify the Food and Drug Administration of a proposed modification to an existing product. The proposed device, the SpeedLock Knotless Fixation Device is substantially equivalent to the SpeedLock Knotless Fixation Device originally cleared under K090615.

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

Arthrocare Corporation % Ms. Laura Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523

AUG - 9 2011

Re: K111044

Trade/Device Name: Speedlock® Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 30, 2011 Received: July 05, 2011

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. 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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Enclosure

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# INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K 111044 |
|----------------------|-------------------------------------|
| Device Name: | SpeedLock® Knotless Fixation System |
| Indications for Use: | |

The SpeedLock Knotless Fixation Device 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)

AND/OR X

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KL 111/044

page v

510(k) Number