# K080447: Surgicraft Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgicraft, Ltd.
- Decided: Jun 13, 2008 after 115 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: 4 generations back to K990987 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.
- K071157: Stryker Peek and Titanium Soft Eyelet Anchors, Stryker Endoscopy (2007) Summary page 1.
- K973775: Harpoon Suture Anchors, Biomet, Inc. (1998) Summary page 1.
- K012572: Soft Tissue Screw and Washer, Biomet, Inc. (2001) Summary page 1.

## Indications for use
The Surgicraft Screw Fixation System is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: * Rotator Cuff Repair * Bankart Repair * SLAP Lesion Repair * Acromio-Clavicular Separation Repair * Capsular Shift/Capsulolabral Reconstruction * Biceps Tenodesis * Deltoid Repair. Elbow, Wrist, Hand: * Scapholunate Ligament Reconstruction * Ulnar Collateral Ligament Reconstruction * Radial Collateral Ligament Reconstruction * Biceps Tendon Reattachment. Foot and Ankle: * Medial Instability Repair/Reconstruction * Lateral Instability Repair/Reconstruction * Achilles Tendon Repair/Reconstruction * Midfoot Reconstruction * Hallux Valgus Reconstruction. Knee: * Extra Capsular Repairs * Medial Collateral Ligament * Lateral Collateral Ligament * Posterior Oblique Ligament * Illiotibial Band Tenodesis * Patellar Tendon Repair. Pelvis: * Bladder Neck Suspension Procedures.

Source page: https://510kreport.com/device/K080447
Methodology: https://510kreport.com/methodology