# K111000: Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Jul 28, 2011 after 108 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: 10 generations back to K911837 (1991). 65 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090075: Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258, Parcus Medical, LLC (2009) Summary page 1.
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.
- K000797: Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01, Orthopaedic Biosystems, Ltd. (2000) Summary page 1.

## Most influential descendants
- K201083: Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors (2020), 3 descendants of its own
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi (2021), 1 descendant of its own
- K242296: VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (2024), 0 descendants of its own
- K212739: ActiFlip (2021), 0 descendants of its own

## Indications for use
The Parcus MiTi Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromnioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. HandWrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Source page: https://510kreport.com/device/K111000
Methodology: https://510kreport.com/methodology