# K071586: Bioraptor 2.3 PK Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Division
- Decided: Aug 17, 2007 after 67 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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: 4 generations back to K961555 (1996). 6 ancestors in all.
121 later devices descend from it; 23 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063726: PLC Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2007) Summary page 1.
- K061154: Kinsa Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor (2010), 16 descendants of its own

## Recalls of this device
- Oct 29, 2024 · Class II · Z-0581-2025: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

## Indications for use
The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip — Hip capsule repair; Acetabutar labrum reattachment Shoulder — Capsular stabilization; Bankart repair; Anterior shoulder instability; 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 instability repairs/reconstructions; AchiLles tendon repairs/reconstructions; Midfoot reconstructions; Metatarsal ligament/tendon repairs/reconstructions; Bunionectomy Elbow, Wrist, and Hand — Biceps tendon reattachment; Ulnar or radial collateral ligament reconstructions; Lateral epicondylitis repair Knee — Extra-capsular repairs: Medial collateral ligament; Lateral collateral ligament; Posterior oblique ligament; PateLilar realignment and tendon repairs; Vastus medialis obliquous advancement; Iliotibial band tenodesis

Source page: https://510kreport.com/device/K071586
Methodology: https://510kreport.com/methodology