# K063726: PLC Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: Mar 6, 2007 after 81 days
- Product code: HRS (Plate, Fixation, Bone)
- 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 K961555 (1996). 4 ancestors in all.
122 later devices descend from it; 1 cites it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- K071586: Bioraptor 2.3 PK Suture Anchor (2007), 121 descendants of its own
- K082215: Osteoraptor Suture Anchor (2008), 46 descendants of its own
- K093428: Smith & Nephew Knotless Instability Anchor (2009), 41 descendants of its own
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an (2012), 29 descendants of its own
- K083635: Smith & Nephew Biosure PK Interference Screw (2009), 21 descendants of its own

## Indications for use
The Smith & Nephew PLC suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis Foot and Ankle Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Knee Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis Hip Capsular repair Acetabular labral repair

Source page: https://510kreport.com/device/K063726
Methodology: https://510kreport.com/methodology