# K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 23, 2006 after 83 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 2 generations back to K961555 (1996). 3 ancestors in all.
477 later devices descend from it; 16 cite it directly.
0 of 481 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972326: Peba Anchor/Suture Combination, Orthopaedic Biosystems, Ltd. (1998) Summary page 1.
- K031685: Tag Rod Bioraptor Suture Anchor 7209317, 7209318, Smith & Nephew, Inc. (2003). Our reading of the summary gave K031683, FDA’s number for Tox Ammonia Calibrator (Bayer Healthcare, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioRaptor 2.9”.

## Most influential descendants
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family (2006), 283 descendants of its own
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew (2007), 227 descendants of its own
- K061154: Kinsa Suture Anchor (2006), 162 descendants of its own
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew (2009), 159 descendants of its own
- K071704: Sleeve and Button Soft Tissue Devices (2007), 142 descendants of its own

## Indications for use
The Smith & Nephew BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 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/K053344
Methodology: https://510kreport.com/methodology