HEALIX TI ANCHOR by DEPUY MITEK, A JOHNSON & JOHNSON CO.

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, Patella 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 is a non-absorbable threaded suture anchor manufactured of Titanium material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in 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 The Healix Anchors are currently offered with absorbable tissue. Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

AI/ML Overview

The provided text is a 510(k) summary for the Healix Ti Anchor, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or performance testing that would generate the kind of data requested in your prompt. This type of submission relies on comparisons to already approved devices.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size, ground truth, MRMC study, training set information) are not applicable or available within this document.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not applicable / Not provided. The 510(k) summary states, "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." It does not list specific acceptance criteria (e.g., pull-out strength, fatigue life) or provide quantitative performance data for such criteria directly within this document. The "tests" performed are implicit in demonstrating substantial equivalence, likely through mechanical bench testing, but the details are not given here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. No specific 'test set' in the context of clinical or performance data is described in this summary. The substantial equivalence argument relies on comparison to predicate devices and likely bench testing, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth, in the context of expert consensus or clinical outcomes, is not relevant to this 510(k) submission, which is for a mechanical bone anchor and focused on substantial equivalence to existing devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. Adjudication methods are typically for clinical studies or image interpretation, which are not detailed here.

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

Not applicable. This device is a mechanical bone anchor, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This device is a mechanical bone anchor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided. Ground truth in the sense of clinical outcomes or expert labels is not part of this 510(k) summary for a mechanical device. The "ground truth" for substantial equivalence for such a device is typically established through a combination of engineering analysis, material properties testing, and mechanical performance tests (e.g., pull-out strength, fatigue) compared against the predicate devices. These specific tests and their "ground truth" values (e.g., meeting a certain strength threshold) are not detailed in this high-level summary.

8. The sample size for the training set

Not applicable. This document describes a mechanical medical device, not a machine learning model, so there is no 'training set'.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device.

Summary based on the document:

The provided document is a 510(k) summary for the Healix Ti Anchor. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present performance data against specific acceptance criteria from a primary clinical study. The "study that proves the device meets the acceptance criteria" is implicitly the "performance and safety testing" mentioned, but the details of these tests, specific criteria, and quantitative results are not included in this summary. Such details would typically be found in the comprehensive 510(k) submission itself, but not in this summary section.

Summary

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Koby2 P. 1/2

SECTION 2 -- 510(k) SUMMARY

ﭘﺎﮐﺴﺘﺎﻥ ﮐﮯ ﺷﮩﺮ

	Healix Ti Anchor	NOV 07 2008
Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Kristine ChristoRegulatory Affairs Project LeadDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone:508-828-3359Facsimile:508-828-3750e-mail: KChristo@Dpyus.jnj.com
Name of Medical Device	Classification Name:	Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fasteners
	Common/Usual Name:	Bone Anchor
	Proprietary Name:	Healix Ti Anchor
Substantial Equivalence	Healix Ti Anchor is substantially equivalent to:
	Mitek Healix Anchor K071481(Aug 9, 2007)Fastin RC Anchor K060664,K0041075 (June 6, 2006; Nov 9, 2004).Super QA+ Anchor K052631 (Oct 21, 2005)Orthocord, violet (size #2) suture, K040004 (April 13, 2004)Orthocord blue (size #2) suture, K043298 (Dec 10, 2004).
	The Healix Ti Anchor is also similar to the Arthrex Corkscrew FTAnchor (K061863 and K061665) and the Arthrex Biocorkscrew Anchor(K061863 and K043337).
Device Classification	This device carries an FDA product code MBI and HWC, and isclassified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth orthreaded metallic bone fixation fasteners under 21 CFR 888.3040.

Confidential

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Device Description

Indications for Use

The Healix Ti Anchor is intended for:

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella 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.

Safety and Performance

Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Healix Ti Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Premarket Notification: Traditional Healix Ti Anchor

Confidential

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitck A Johnson & Johnson company % Ms. Kristine Christo Regulatory Affairs Project Lead 325 Paramount Drive Raynham, Massachusetts 02767

NOV 0 7 2008

Re: K082282

Trade/Device Namc: Healix Ti Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR Dated: August 8, 2008 Received: August 11, 2008

Dear Ms. Christo:

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. Kristine Christo

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

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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510(k) Number (if known): K082282

Device Name: Healix Ti 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, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Hip: Capsular repair, acetabular labral repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K082282
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Prescription Use	√	OR	Over-the-Counter Use	ℵo
			(Per 21 CFR 801.109)

Premarket Notification: Traditional Healix Ti Anchor

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.