# K090128: Tac-Tite (TM)

- Pathway: 510(k) (Special)
- Applicant: Core Essence Orthopaedics, Inc.
- Decided: Mar 19, 2009 after 57 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961555 (1996). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X, Core Essence Orthopaedics, LLC (2007) Summary page 3.

## Most influential descendants
- K111716: Knotless Suture Fixation System (2011), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K090128
Methodology: https://510kreport.com/methodology