# K060664: Fastin RC Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek
- Decided: Jun 6, 2006 after 85 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945203 (1995). 2 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945203: Mitek Thraded Anchor (Mta), Mitek Surgical Products, Inc. (1995) Summary page 2.
- K003816: Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium Corkscrew 6.5MM, Arthrex, Inc. (2001) Summary page 2.

## Most influential descendants
- K082282: Healix TI Anchor (2008), 21 descendants of its own
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend (2011), 15 descendants of its own
- K211002: Grappler Suture Anchor System (2021), 6 descendants of its own
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord (2011), 6 descendants of its own
- K222091: Grappler Suture Anchor System (2022), 3 descendants of its own

## Indications for use
The FASTIN RC Anchors are indicated for the following: * Shoulder: Rotator Cuff Repair, SLAP Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair and SLAP Repair * Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair * Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Elbow: Biceps Tendon Reattachment, Tennis Elbow, Ulnar or Radial Collateral Ligament Reconstruction.

Source page: https://510kreport.com/device/K060664
Methodology: https://510kreport.com/methodology