# K082215: Osteoraptor Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Division
- Decided: Nov 3, 2008 after 89 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961555 (1996). 7 ancestors in all.
46 later devices descend from it; 8 cite it directly.
0 of 54 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.
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 1.

## Most influential descendants
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an (2012), 29 descendants of its own
- K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor (2010), 16 descendants of its own
- K112526: Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors (2012), 13 descendants of its own
- K101459: Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 (2011), 10 descendants of its own
- K152566: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor,  HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors (2015), 6 descendants of its own

## Recalls of this device
- Aug 6, 2013 · Class II · Z-2226-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2222-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2223-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2224-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2220-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2221-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2227-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2228-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2225-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

## Indications for use
The Smith & Nephew OSTEORAPTOR Suture Anchor is 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 Haltux valgus repairs Media[ or lateral instability repairs/reconstructions 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 Iliotibial 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/K082215
Methodology: https://510kreport.com/methodology