# K122805: Parcus Draw Tight 1.8MM Single-Loaded Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Feb 5, 2013 after 145 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 12 generations back to K911837 (1991). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102326: Parcus 3.5MM Peek CF Push-in Suture Anchor, Parcus Medical, LLC (2010) Summary page 1.
- K120942: Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus Triple Twist 5.5MM Peek Suture Anc, Parcus Medical, LLC (2012) Summary page 1.
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor, Biomet, Inc. (2011) Summary page 1.

## Most influential descendants
- K213109: Auxilock Draw Tight Suture-Based Anchor (2022), 0 descendants of its own

## Indications for use
The Parcus Draw Tight 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, Midifoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Source page: https://510kreport.com/device/K122805
Methodology: https://510kreport.com/methodology