TAC-TITE (TM)

K090128 · Core Essence Orthopaedics, Inc. · GAT · Mar 19, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090128
• Device Name: TAC-TITE (TM)
• Applicant: Core Essence Orthopaedics, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 19, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

TAC-tite™ Suture Anchor System consists of threaded titanium (ASTM F136/ISO 5832-3) anchors (5.5mm/7.0mm) preloaded with size 2 UHMW polyethylene UltraFibre™ sutures. Device includes single-use driver and handpiece for delivery. Used by orthopedic surgeons in clinical/OR settings to secure soft tissue to bone during reconstructive procedures (e.g., rotator cuff, Achilles tendon, ligament repairs). Self-drilling/self-tapping anchor design facilitates bone fixation. Sterile, single-use device.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Titanium (ASTM F136/ISO 5832-3) anchor body, UHMW polyethylene suture. Design: Threaded, self-drilling, self-tapping anchor. Sizes: 5.5mm and 7.0mm diameters. Delivery: Single-use driver and handpiece. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder, elbow, hand, wrist, ankle, and foot procedures, including ligament, tendon, and capsule repairs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• reNOVO Suture Anchors (K071520)

Submission Summary (Full Text)

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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 - [phone] Fax - [phone]

## 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 [phone] or [phone] 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 |
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| (Division Sign-Oft) | |
| for Division of Surgical, Orthopedic,<br>and Restorative Devices | |
| 510(k) Number | K090/28 |