# K232513: X-Twist Biocomposite Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Parcus Medical
- Decided: Sep 18, 2023 after 31 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K971358 (1997). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221135: X-Twist PEEK Suture Anchor, Parcus Medical, LLC (2022) Summary page 4.
- K183501: Parcus Twist AP Suture Anchors, Parcus Medical, LLC (2019) Summary page 4.

## Indications for use
The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications: Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

Source page: https://510kreport.com/device/K232513
Methodology: https://510kreport.com/methodology