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 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 Description

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

Acceptance Criteria (Inferred)	Reported Device Performance
Material and design similarity to predicate device.	The Healix Ti anchor component of the proposed device has the same materials and design as the predicate Healix Ti anchor with Orthocord (K082282). The Permacord suture is the same as referenced in Healix Advance™ Anchor with Permacord™ (K133794).
Similar indications for use to predicate device.	The Healix Ti Anchor with Permacord has the same indications for use as the predicate device (K082282), covering various repairs in Shoulder, Foot/Ankle, Knee, Elbow, and Hip.
Equivalent principal operation to predicate device.	The proposed device's principal operation is the same as the predicate Healix Ti anchor.
Demonstrated mechanical integrity and fixation strength.	"Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing." "Results of performance testing have demonstrated that the proposed device is suitable for its intended use." (No specific numerical pull-out strength reported in this summary).
Sterilization method and shelf life similar to predicate device	"The proposed Healix Ti Anchor with Permacord suture is substantially equivalent to Healix Ti Anchor with Orthocord suture (K082282) in terms of design, indications for use, performance data, sterilization method and shelf life."

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing." However, it does not provide any details regarding the sample size used for these tests, nor the data provenance (country of origin, retrospective or prospective). Given the nature of a 510(k) summary, these granular details are often found in the full submission, not the publicly available summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this document. The device in question is a medical implant (suture anchor), not an AI or diagnostic device that requires expert review for ground truth establishment. The "ground truth" for this device would be its physical and mechanical performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a medical implant, not an AI or diagnostic tool that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This is not applicable as the device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and mechanical testing data, primarily "pull out testing" to demonstrate its fixation strength in bone. It also relies on the established performance and safety record of its predicate devices.

8. The Sample Size for the Training Set

This is not applicable as the device is hardware (medical implant) and not an AI algorithm that would require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as the device is hardware and does not have a training set or associated ground truth in the context of machine learning.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Date Prepared: September 11, 2014
Contact Person	Tracey HannonRegulatory Affairs SpecialistDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-880-8033Facsimile: 508-977-6911e-mail: thannon@its.jnj.com
Name ofMedical Device	Proprietary Name: Healix Ti™ Anchor with Permacord™Classification Name: Smooth or threaded metallic bone fixation fastenersCommon Name: Suture Anchor
SubstantialEquivalence	The Healix Ti™ Anchor with Permacord™ is substantially equivalent to:K082282 Healix Ti™ Anchor with Orthocord®Reference Devices:• K133794 Healix Advance™ Anchor with Permacord™• K140324 Rigidloop™ Adjustable Cortical Fixation System
DeviceClassification	Healix Ti™ Anchor with Permacord™ is classified as:• Smooth or threaded metallic bone fixation fastener, classified as Class II, product code MBI, regulated under 21 CFR 888.3040.
DeviceDescription	The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloadedon a disposable inserter assembly intended for fixation of suture to bone. The HealixTi Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. TheHealix Ti Anchor with Permacord suture is supplied sterile and is for single use only.
TechnologicalCharacteristics	The proposed Healix Ti anchor with Permacord suture has the same anchor materialsand design as the predicate Healix Ti anchor with Orthocord (K082282). Theproposed device principal operation is the same as predicate Healix Ti anchor
Indications forUse	The Healix Ti Anchor is intended for:
	Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral 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, Patella tendon repairand secondary fixation in ACL / PCL reconstruction repair.
	Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction.
	Hip: Capsular repair, acetabular labral repair.
Non clinicalTesting	Verification activities were performed on the implant and / or its predicates. Testingassessment includes pull out testing.
Safety andPerformance	Results of performance testing have demonstrated that the proposed device is suitablefor its intended use.
	Based on similarities in the indications for use, technological characteristics, andperformance in comparison to the predicate device, the proposed Healix Ti Anchorwith Permacord suture has shown to be substantially equivalent to the predicate deviceunder the Federal Food, Drug and Cosmetic Act.
Conclusion	The proposed Healix Ti Anchor with Permacord suture is substantially equivalent toHealix Ti Anchor with Orthocord suture (K082282) in terms of design, indications foruse, 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).

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.