# K113730: Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture Anchors

- Pathway: 510(k) (Special)
- Applicant: Parcus Medical, LLC
- Decided: Jan 17, 2012 after 29 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
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K193295: Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor (2020), 5 descendants of its own
- K170327: Parcus SLiK Anchors (2017), 5 descendants of its own
- K221135: X-Twist PEEK Suture Anchor (2022), 3 descendants of its own
- K200503: ATL Anchors (2020), 2 descendants of its own
- K243712: WasherCap™ Mini Fixation System (Model 45) (2025), 1 descendant of its own

## Indications for use
The Parcus 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, 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. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. Hip: Acetabular Labral Repair (35 and 45 Knotless only)

Source page: https://510kreport.com/device/K113730
Methodology: https://510kreport.com/methodology