# K251627: BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 25, 2025 after 28 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K961555 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Smith & Nephew, Inc. (2015) Summary page 7.

## Indications for use
The Smith & Nephew BIORAPTOR◊ Suture Anchor is indicated for the reattachment of soft tissue to bone for the following indications: Hip: Hip Capsule Repair -Acetabular labrum reattachment/reconstruction 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 Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis The Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: 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 Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis

Source page: https://510kreport.com/device/K251627
Methodology: https://510kreport.com/methodology