# K193295: Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Parcus Medical, LLC
- Decided: Jan 23, 2020 after 57 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: 1 generation back to K113730 (2012). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113730: Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture Anchors, Parcus Medical, LLC (2012) Summary page 4.

## Most influential descendants
- K200503: ATL Anchors (2020), 2 descendants of its own
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi (2021), 1 descendant of its own
- K260317: Artelon Convenience Kits (2026), 0 descendants of its own
- K253538: TeKBrace Knotless Anchor (2026), 0 descendants 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

## Indications for use
The Parcus Knotless PEEK and 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. Hip Acetabular Labral Repair

Source page: https://510kreport.com/device/K193295
Methodology: https://510kreport.com/methodology
