# K142948: BIOSURE REGENESORB interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 13, 2015 after 95 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K961555 (1996). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140879: Biosure Healicoil PK Interference Screw, Smith & Nephew, Inc. (2014) Summary page 5.
- K080358: Plla, HA Screw, Smith & Nephew Inc., Endoscopy Div. (2008) Summary page 5.
- K123393: Healicoil Suture Anchor with Regenesorb, Smith & Nephew, Inc. (2013) Summary page 5.

## Recalls of this device
- Nov 24, 2025 · Class II · Z-0957-2026: Removal of affected lot of screws due to labeling error.

## Indications for use
The BIOSURE REGENESORB 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 Iliotibial 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 Carpometacarpal joint arthroplasty NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone procedures.

Source page: https://510kreport.com/device/K142948
Methodology: https://510kreport.com/methodology