# K013057: Biocuff,C, Models 236018, 236028, 236036

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Inc.
- Decided: Oct 12, 2001 after 30 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: 3 generations back to K792022 (1979). 9 ancestors in all.
79 later devices descend from it; 2 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001378: Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736, Bionx Implants, Inc. (2000) Summary page 1.
- K974876: Bionx Distal Radius Screw, Bionx Implants, Inc. (1998) Summary page 2.
- K992947: Cannulated Smartscrew Models 224540C, 224570C, Bionx Implants, Ltd. (1999) Summary page 2.

## Most influential descendants
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own

## Indications for use
Properly used, in the presence of adequate immobilization, absorbable BioCull C™ screw/washer maintains proximily between soft tissue and bone to facilitate the soft tissue reattachment. The BioCuff C™ loses its strength over 20 to 50 weeks while the Icsion of the tendon is healing. The BioCuff C™ js not intended for usc in and is contraindicated for: 1) Insufficient quality or quantity of bone, 2) Foreign body sensitivity to the implant material. Where the matenal is suspecled a test should be made prior to implantation to rulc out sensitivity. 3) Patients with active sepsis or infection. 4) Conditions, which tend to limit the patient’s abijlity or willingness to restrict aclivities or follow directions during the healing and rehabilitation period.

Source page: https://510kreport.com/device/K013057
Methodology: https://510kreport.com/methodology