HEALIX ANCHOR

K071481 · Depuy Mitek, A Johnson & Johnson Company · HWC · Aug 9, 2007 · Orthopedic

Device Facts

• Record ID: K071481
• Device Name: HEALIX ANCHOR
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Aug 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Healix Anchor is intended for: Indications for Use Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair: Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

Device Story

Healix Anchor is a non-absorbable, threaded bone anchor manufactured from polyetheretherketone (PEEK). Device is preloaded on a disposable inserter assembly; used by surgeons in orthopedic procedures to fixate #2 sutures to bone. Suture options include Panacryl (absorbable), Ethibond (non-absorbable), or Orthocord (partially absorbable), with optional tapered needles. Available in 4.5mm, 5.5mm, and 6.5mm diameters. Device provides mechanical fixation of soft tissue to bone, facilitating healing in various orthopedic repairs.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and performance evaluation.

Technological Characteristics

Material: PEEK (polyetheretherketone). Threaded bone anchor design. Sizes: 4.5mm, 5.5mm, 6.5mm outer diameters. Suture compatibility: #2 sutures (Panacryl, Ethibond, Orthocord). Delivery: Disposable inserter assembly. Non-absorbable anchor body.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder (rotator cuff, Bankart, SLAP, biceps, AC, deltoid, capsular repairs), foot/ankle (stabilization, Achilles repair), knee (ligament repairs, IT band tenodesis), elbow (biceps, ligament reconstruction), and hip (capsular, acetabular labral repair) procedures.

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

• Mitek Spiralok Anchor (K041069 and K060271)
• Arthrex Corkscrew FT Anchor (K061863 and K061665)
• Arthrex Biocorkscrew Anchor (K061863 and K043337)

Submission Summary (Full Text)

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## 14071481 (pg 1/2)

# SECTION 2 – 510(k) SUMMARY

#### Healix Anchor

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt<br>Project Management Lead, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br>Telephone: [phone]<br>Facsimile: 508-828-3750<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name: Fastener, Fixation, Nondegradable, Soft<br>Tissue Smooth or threaded metallic bone<br>fixation fasteners |
| | Common/Usual Name: Bone Anchor |
| Substantial Equivalence | Proprietary Name: Healix Anchor<br>Healix Anchor is substantially equivalent to:<br>Mitek Spiralok Anchor (K041069 and K060271). The Healix Anchor<br>is also similar to the Arthrex Corkscrew FT Anchor (K061863 and<br>K061665) and the Arthrex Biocorkscrew Anchor (K061863 and<br>K043337). |
| Device Classification | This device carries an FDA product code MBI and HWC, and is<br>classified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth or<br>threaded metallic bone fixation fasteners under 21 CFR 888.3040. |
| Device Description | The Healix Anchor is a non-absorbable threaded suture anchor<br>manufactured of polyetheretherketone (PEEK) material. The threaded<br>anchor comes preloaded on a disposable inserter assembly and is<br>intended for fixation of #2 suture to bone. The anchor is provided in |

Healix Anchor

.

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### KO71481 (pg 212)

three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

#### The Healix Anchor is intended for: Indications for Use Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair: Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair. Results of performance and safety testing have demonstrated that the Safety and Performance modified device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Healix Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Premarket Notification: Traditional Healix Anchor

Confidential

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a bird or a human figure with flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitek a Johnson & Johnson Company % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, MA 02767

AUG - 9 2007

Re: K071481

Trade/Device Name: Healix Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: May 25, 2007 Received: May 29, 2007

Dear Ms. Forstadt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 – Ms. Ruth C. Forstadt

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrig

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): _ ½07 |48|

Device Name: Healix Anchor

Healix Anchor is indicated for use in the following:

Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

Prescription Use

OR

Over-the -Counter Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buelher for MHM
(Division Sign-Off)

and Neurological Devicest

**510(k) Number** K071481