# K102326: Parcus 3.5MM Peek CF Push-in Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Nov 15, 2010 after 90 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: 11 generations back to K911837 (1991). 69 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091094: Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264, Parcus Medical, LLC (2009) Summary page 1.
- K031685: Tag Rod Bioraptor Suture Anchor 7209317, 7209318, Smith & Nephew, Inc. (2003) 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.

## Most influential descendants
- K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant (2014), 2 descendants of its own
- K122805: Parcus Draw Tight 1.8MM Single-Loaded Suture Anchor (2013), 1 descendant of its own
- K222564: Treace Medical Concepts (TMC) Hammertoe Fixation System (2022), 0 descendants of its own
- K213109: Auxilock Draw Tight Suture-Based Anchor (2022), 0 descendants of its own
- K151241: Synchro-Medical TIGER TRACK Screw System (2015), 0 descendants of its own

## Indications for use
The Parcus 3.5mm PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair. Acromioclavicular 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. Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Source page: https://510kreport.com/device/K102326
Methodology: https://510kreport.com/methodology