(57 days)
Not Found
No
The device description and intended use are purely mechanical, describing a suture anchor and its application. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is intended to secure soft tissue to bone for various repairs and reconstructions across multiple anatomical sites (e.g., Bankart Repair, Achilles Tendon Repair), which falls under the definition of a therapeutic intervention.
No
The provided information describes a surgical implant (TAC-tite™ Suture Anchors) used for securing soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium and UHMW polyethylene, along with a driver and handpiece, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used to secure soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details a physical implantable device (suture anchor) made of titanium and sutures, along with a delivery system. This aligns with a surgical implant, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing any kind of diagnostic test outside of the body.
Therefore, the TAC-tite™ Suture Anchors are a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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
Product codes
MBI, GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Hand, Wrist, Ankle, Foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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
3
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
4
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
5
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 |