# K140879: Biosure Healicoil PK Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 21, 2014 after 105 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: 6 generations back to K961555 (1996). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 1.
- K083226: Smith & Nephew Peek Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 1.
- K042552: Bio-Core Interference Screw, Biomet, Inc. (2004) Summary page 2.

## Most influential descendants
- K142948: BIOSURE REGENESORB interference Screw (2015), 0 descendants of its own

## Indications for use
The BIOSURE HEALICOIL PK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications: Knee ACL repairs. PCL repairs, Extra-capsular repairs, Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquus advancement, Iliotibiall band tenodesis Shoulder Acromioclavicular separation repairs. Biceps tenodesis Foot and Ankle Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Flexor hullucis longus (FHL), Tendon transfers Elbow, Wrist, and Hand Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers, Carpomnedicarpal joint arthroplasty,

Source page: https://510kreport.com/device/K140879
Methodology: https://510kreport.com/methodology