4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,

K142574 · Depuy Mitek, A Johnson & Johnson Company · MBI · Oct 24, 2014 · Orthopedic

Device Facts

• Record ID: K142574
• Device Name: 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MBI · Orthopedic
• Decision Date: Oct 24, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Healix Ti Anchor is intended for: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Foot/Ankle: Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

Device Story

Healix Ti Anchor with Permacord is a non-absorbable titanium suture anchor preloaded on a disposable inserter; used for fixation of suture to bone in orthopedic surgeries. Device facilitates soft tissue-to-bone attachment; surgeon inserts anchor into bone; suture secures tissue. Used in OR by orthopedic surgeons. Benefits include stable fixation for various ligament and tendon repairs. Supplied sterile for single use.

Clinical Evidence

Bench testing only. Verification activities, including pull-out testing, were performed on the implant and its predicates to demonstrate suitability for the intended use.

Technological Characteristics

Titanium bone fixation fastener; non-absorbable Permacord suture; disposable inserter assembly; sizes 4.5mm, 5.5mm, 6.5mm; sterile; single-use.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder, foot/ankle, knee, elbow, and hip orthopedic procedures, including rotator cuff, ligament, and 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

• Healix Ti Anchor with Orthocord (K082282)

Reference Devices

• Healix Advance Anchor with Permacord (K133794)
• Rigidloop Adjustable Cortical Fixation System (K140324)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a group of people in profile. The logo is black and white.

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

October 24, 2014

Depuy Mitek, A Johnson & Johnson Company Ms. Tracey Hannon Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K142574

Trade/Device Name: Healix Ti with Permacord Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 25, 2014 Received: September 26, 2014

Dear Ms. Hannon:

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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K142574

#### Device Name Healix Ti with Permacord

Indications for Use (Describe)

The Healix Ti Anchor is intended for:

- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Foot/Ankle:
- Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hip: Capsular Repair, Acetabular Labral Repair

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# SECTION 2 - 510(k) SUMMARY

Healix™™ Anchor with Permacord™

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br>Date Prepared: September 11, 2014 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tracey Hannon<br>Regulatory Affairs Specialist<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: Healix Ti™ Anchor with Permacord™<br>Classification Name: Smooth or threaded metallic bone fixation fasteners<br>Common Name: Suture Anchor |
| Substantial<br>Equivalence | The Healix Ti™ Anchor with Permacord™ is substantially equivalent to:<br>K082282 Healix Ti™ Anchor with Orthocord®<br>Reference Devices:<br>• K133794 Healix Advance™ Anchor with Permacord™<br>• K140324 Rigidloop™ Adjustable Cortical Fixation System |
| Device<br>Classification | Healix Ti™ Anchor with Permacord™ is classified as:<br>• Smooth or threaded metallic bone fixation fastener, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. |
| Device<br>Description | The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded<br>on a disposable inserter assembly intended for fixation of suture to bone. The Healix<br>Ti Anchors are manufactured of Titanium material. Permacord suture is non-<br>absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The<br>Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only. |
| Technological<br>Characteristics | The proposed Healix Ti anchor with Permacord suture has the same anchor materials<br>and design as the predicate Healix Ti anchor with Orthocord (K082282). The<br>proposed device principal operation is the same as predicate Healix Ti anchor |
| Indications for<br>Use | The Healix Ti Anchor is intended for: |
| | Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction; |
| | Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; |
| | Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair<br>and secondary fixation in ACL / PCL reconstruction repair. |
| | Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction. |
| | Hip: Capsular repair, acetabular labral repair. |
| Non clinical<br>Testing | Verification activities were performed on the implant and / or its predicates. Testing<br>assessment includes pull out testing. |
| Safety and<br>Performance | Results of performance testing have demonstrated that the proposed device is suitable<br>for its intended use. |
| | Based on similarities in the indications for use, technological characteristics, and<br>performance in comparison to the predicate device, the proposed Healix Ti Anchor<br>with Permacord suture has shown to be substantially equivalent to the predicate device<br>under the Federal Food, Drug and Cosmetic Act. |
| Conclusion | The proposed Healix Ti Anchor with Permacord suture is substantially equivalent to<br>Healix Ti Anchor with Orthocord suture (K082282) in terms of design, indications for<br>use, performance data, sterilization method and shelf life. |

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(K082282). The Permacord suture is the same suture as referenced in Healix
Advance™ Anchor with Permacord™ (K133794).