# K101459: Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 27, 2011 after 246 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: 6 generations back to K961555 (1996). 13 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082215: Osteoraptor Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2008) Summary page 1.
- K070925: Modification to: Bioknotless BR Anchor / Lupine BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.

## Most influential descendants
- K180361: MICRORAPTOR REGENESORB Suture Anchor (2018), 4 descendants of its own
- K123393: Healicoil Suture Anchor with Regenesorb (2013), 4 descendants of its own
- K181746: MICRORAPTOR Knotless Suture Anchor (2018), 3 descendants of its own
- K251809: Arthrex FiberTak Suture Anchor (2025), 1 descendant of its own
- K151105: Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa (2015), 1 descendant of its own

## Indications for use
The Smith & Nephew Osteoraptor 11 Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Foot and Ankle Hallux valgus repairs Medial or lateral instability repairstreconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Hip Hip capsule repair -Acetabular labrum reattachment Knee Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs - Vastus medialis obliquous advancement 1] lotibial band tenodesis 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

Source page: https://510kreport.com/device/K101459
Methodology: https://510kreport.com/methodology