# K011985: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 2, 2001 after 129 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: 4 generations back to K904436 (1990). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982963: Polymer Threaded Anchor / Suture Combination, Orthopaedic Biosystems, Ltd. (1998) Summary page 1.
- K993115: Multitak SS, Bonutti Research, Inc. (1999) Summary page 1.

## Most influential descendants
- K042038: MTF Allograft Anchor (2004), 1 descendant of its own
- K061498: Allofix Anchor, 5.0 MM Anchor (2006), 0 descendants of its own
- K053339: Allofix Anchor (2006), 0 descendants of its own

## Indications for use
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand: Scapholunate ligament reconstructions Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Knee: Extra-capsular repairs: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

Source page: https://510kreport.com/device/K011985
Methodology: https://510kreport.com/methodology