# K101100: Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec
- Decided: Aug 26, 2010 after 128 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911837 (1991). 98 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091549: Conmed Linvatec Soft Tissue to Bone System, Linvatec Corp. (2009) Summary page 1.
- K053561: Bio-Mini Revo Suture Anchor, Conmed Linvatec (2006) Summary page 1.
- K052080: Matryx Interference Screw, Linvatec Biomaterials, Inc. (2005) Summary page 1.

## Most influential descendants
- K170501: CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (2017), 2 descendants of its own
- K171592: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver (2017), 1 descendant of its own
- K180759: SECULOK™ Suture Anchor (2018), 0 descendants of its own
- K180763: CuffLink Implant System Biocomposite (2018), 0 descendants of its own
- K121890: Genesys Pressft Suture Anchor (2012), 0 descendants of its own

## Recalls of this device
- Jul 14, 2026 · Class II · Z-3018-2026: Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
- Mar 6, 2013 · Class II · Z-1619-2013: Incorrect blue/white suture was used.

## Indications for use
The ConMed Linvatec CrossFTTM BC Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendon, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Source page: https://510kreport.com/device/K101100
Methodology: https://510kreport.com/methodology
