TAC-tite™ Suture Anchors are intended to secure soft tissue to bone of: The Shoulder: Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

Device Description

The TAC-tite™ Suture Anchors are available in 5.5mm and 7.0mm diameters. The TAC-tite™ Suture Anchors are available with a threaded titanium (ASTM F136/ ISO 5832-3) anchor body (that provides a self drilling and self tapping thread). The TAC-tite™ anchor eyelet is designed to accept size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece delivers the preloaded anchor into the bone. The TAC-tite " Suture Anchor will be provided sterile for single use application.

AI/ML Overview

This 510(k) summary (K090128) for the TAC-tite™ Suture Anchor System does not contain details about specific acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" of the TAC-tite™ Suture Anchors to a predicate device (reNOVO Suture Anchors, K071520). Substantial equivalence in the FDA 510(k) process means that a new device is as safe and effective as a legally marketed predicate device. This is often demonstrated by showing equivalent intended use, materials, operational principles, and indications for use, rather than through a new, comprehensive performance study with acceptance criteria.

Therefore, most of the information requested in your prompt cannot be extracted from this document, as it describes a different regulatory pathway.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Cannot be provided. The document does not define specific acceptance criteria (e.g., tensile strength, pull-out force thresholds) or present performance data against such criteria. The basis for clearance is "substantial equivalence" to a predicate, not direct performance testing against new acceptance criteria.

2. Sample size used for the test set and the data provenance:

Cannot be provided. No specific "test set" or associated data (country of origin, retrospective/prospective) for a performance study is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Cannot be provided. This type of information is relevant for studies relying on expert review (e.g., image-based diagnostic devices). This document does not
describe such a study.

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

Cannot be provided. Not applicable as no such study is described.

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:

Cannot be provided. This is a surgical implant; MRMC studies are not relevant. This type of study is typically for diagnostic aids or AI-assisted interpretation of medical images.

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

Cannot be provided. Not applicable. The device is a physical surgical implant, not an algorithm.

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

Cannot be provided. There is no explicit "ground truth" discussed in the context of a performance study for this device within the document. The "truth" for substantial equivalence is implicitly the safety and effectiveness profile of the predicate device.

8. The sample size for the training set:

Cannot be provided. No training set is mentioned as this is a physical device submission, not an AI or data-driven software submission.

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

Cannot be provided. Not applicable as no training set is mentioned.

Summary regarding acceptance criteria and studies:

The provided 510(k) summary for the TAC-tite™ Suture Anchor System (K090128) asserts substantial equivalence to the reNOVO Suture Anchors (K071520) rather than demonstrating performance against specific, pre-defined acceptance criteria through a new clinical or performance study detailed in this document.

The basis for equivalence is stated as "equivalence in intended use, materials, operational principals, and indications." This is a common pathway for medical device clearance when a suitable predicate device exists. The FDA grants clearance when it determines that the new device is as safe and effective as the legally marketed predicate. The "study" mentioned here is essentially a comparative analysis against the predicate device, not a de novo performance study.

Summary

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KU9D128 (pg 1/3)

510(K) SUMMARY

MAR 1 9 2009

Subject 510(k) Number K090128

Sponsor

Core Essence Orthopaedics, Inc.

575A Virginia Drive Fort Washington, PA 19034

FDA Establishment Registration Number

3006283823

Official Contact

Richard Washburn, President Core Essence Orthopaedics, Inc. 575A Virginia Drive Fort Washington, PA 19034 Phone - (215) 310-9534 Fax - (609) 482-4957

Proprietary Name

TAC-tite™ Suture Anchor System

Common Name Suture Anchor

Classification Name and Reference Sec. 888.3040 Smooth or threaded metallic bone fixation fastener

Regulatory Class Class II

Device Product Code/Subsequent Code (Panel 87) MBI/GAT

Date Prepared 18 September, 2012 /f

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KD96128Cpg 2/3)

Brief Description of Device

The TAC-tite™ Suture Anchors are available in 5.5mm and 7.0mm diameters.

The TAC-tite™ Suture Anchors are available with a threaded titanium (ASTM F136/ ISO 5832-3) anchor body (that provides a self drilling and self tapping thread). The TAC-tite™ anchor eyelet is designed to accept size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece delivers the preloaded anchor into the bone.

The TAC-tite " Suture Anchor will be provided sterile for single use application.

Indications for Use

TAC-tite™ Suture Anchors are intended to secure soft tissue to bone of:

The Shoulder:

Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair

The Elbow:

Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair

The Hand and Wrist:

Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons

The Ankle and Foot:

Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

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Image /page/2/Picture/0 description: The image shows a handwritten text string. The text string is "K09D128(pg 3/3)". The text appears to be written in blue ink.

Basis for Substantial Equivalence

The substantial equivalence of the TAC-tite™ Suture Anchors is based on the equivalence in intended use, materials, operational principals, and indications to the reNOVO Suture Anchors covered by K071520.

END OF 510(K) SUMMARY

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird-like figure in flight. The emblem is rendered in blue. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

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

Core Essence Orthopaedics. Inc. % Mr. Richard T. Briganti Engineering Principal 575A Virginia Drive Fort Washington. PA 19034

AUG 1 3 2012

Re: K090128

Trade/Device Name: TAC-tite™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, GAT Dated: February 17, 2009 Received: February 19, 2009

Dear Mr. Briganti:

This letter corrects our substantially equivalent letter of March 19, 2009.

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 requirements of the Act or any Federal statutes and regulations administered by other

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Page 2 - Mr. Richard T. Briganti

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 (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.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark N Melkerson

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

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K090128 (pg 1/1)

Statement of Indications for Use

510 (K) NUMBER IF KNOWN: K090128

MANUFACTURER: Core Essence Orthopaedics, Inc.

DEVICE NAME: TAC-tite™ Suture Anchors

TAC-tite™ Suture Anchors are intended to secure soft tissue to bone of:

The Shoulder: Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair

The Elbow:

Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair

The Hand and Wrist:

Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons

The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

Prescription Use XX

and/or

Over-the-Counter Use NO

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	K Asunli
(Division Sign-Oft)
for Division of Surgical, Orthopedic,and Restorative Devices
510(k) Number	K090/28

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.