HEALIX ADVANCE PEEK ANCHOR

K120449 · Depuy Mitek · HWC · May 11, 2012 · Orthopedic

Device Facts

• Record ID: K120449
• Device Name: HEALIX ADVANCE PEEK ANCHOR
• Applicant: Depuy Mitek
• Product Code: HWC · Orthopedic
• Decision Date: May 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEALIX ADVANCE™ PEEK Anchor is indicated for: Shoulder: Rotator 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 ADVANCE PEEK Anchor is a non-absorbable, threaded suture anchor manufactured from PEEK material; designed for fixation of size 2 suture to bone. Device provided sterile, preloaded on a disposable inserter assembly for single-patient use. Used by surgeons in orthopedic procedures (shoulder, foot/ankle, knee, elbow, hip) to reattach soft tissue to bone. Surgeon inserts anchor into bone; suture facilitates tissue passage and securement. Mechanical fixation provides stability during healing, potentially improving patient outcomes in reconstructive surgeries.

Clinical Evidence

Bench testing only. Design verification activities, specifically anchor torque and anchor pull-out testing, were performed to demonstrate performance against predefined acceptance criteria. No clinical data was required or provided.

Technological Characteristics

Non-absorbable threaded bone anchor; material: PEEK; form factor: preloaded on disposable inserter assembly; energy source: none (mechanical); sterilization: sterile; connectivity: none; software: none.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder, foot/ankle, knee, elbow, and hip 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 PEEK Anchor (K071481)

Submission Summary (Full Text)

{0}------------------------------------------------

## K120449 (pg1/2)

## SECTION 2 - 510(k) SUMMARY

## HEALIX ADVANCE™ PEEK Anchor

MAY 1 1 2012

ﺴﺮ ﺑﺎﻟﻤﺮﺍﺟﻊ -

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Yayoi Fujimaki<br>Regulatory Affairs Senior Associate<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br><br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: HEALIX ADVANCE™ PEEK Anchor<br>Classification Name: Smooth or threaded metallic bone fixation fasteners<br>Common Name: Bone Anchor |
| Substantial<br>Equivalence<br>Facility | The HEALIX ADVANCE PEEK Anchor is substantially equivalent to:<br>• K071481: Healix PEEK Anchor |
| Device<br>Classification | Smooth or threaded metallic bone fixation fasteners, classified as Class II, product<br>code HWC, regulated under 21 CFR 888.3040. |

Premarket Notification: Traditional
HEALIX ADVANCE™ PEEK Anchor

, i

{1}------------------------------------------------

| Device<br>Description | The HEALIX ADVANCE PEEK Anchor is non-absorbable threaded suture anchor<br>manufactured of PEEK material. The anchor comes preloaded on a disposable inserter<br>assembly and is intended for fixation of size 2 suture to bone. The suture options may<br>include needles to facilitate suture passage through tissue. HEALIX ADVANCE<br>PEEK Anchor is provided sterile and is for single patient, use only. | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction; |
| | Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; |
| | Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Posterior Oblique Ligament Repair, Iliotibial Band<br>Tenodesis; |
| | Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction; |
| | Hip: | Capsular repair, Acetabular Labral Repair. |
| Safety and<br>Performance | Non-clinical Testing<br>Design verification activities, such as Anchor Torque and Anchor Pull Out were<br>performed against pre-defined acceptance criteria according to the indicated use.<br>Results of performance testing have demonstrated that the proposed devices are<br>suitable for their intended use.<br>Based on the indications for use, technological characteristics, and comparison to the<br>predicate devices, the proposed HEALIX ADVANCE PEEK Anchor have shown to be<br>substantially equivalent to the predicate devices under the Federal Food, Drug and<br>Cosmetic Act. | |

・

.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle in flight, rendered in blue lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

DePuy Mitek, Inc a Johnson and Johnson Company % Ms. Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, MA 02767

JUL - 2 2012

Re: K120449

Trade/Device Name: HEALIX ADVANCE™ PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 11, 2012 Received: May 11, 2012

Dear Ms. Fujimaki:

This letter corrects our substantially equivalent letter of May 11, 2012.

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 (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 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

{3}------------------------------------------------

Page 2 - Ms. Yayoi Fujimaki

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 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. Milkeron

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

{4}------------------------------------------------

## Indications for Use

KIZD449 (pa 1/1) 510(k) Number (if known): Device Name: HEALIX ADVANCE™ PEEK Anchor Indications for Use:

The HEALIX ADVANCE™ PEEK Anchor is indicated for:

| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis,<br>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, 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 ____x

AND/OR

Over-The-Counter Use _

(Pari 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(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

510(k) Number k120449

Page 1 of 1

Premarket Notification: Traditional HEALIX ADVANCE™ PEEK Anchor