# K122059: All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 18, 2013 after 248 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904436 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor, Biomet, Inc. (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K102018: Norian Reinforced, Norian Reinforced Fast Set Putty, Synthes USA Products, LLC (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K163034: SUTUREFIX Curved Suture Anchor (2016), 0 descendants of its own

## Recalls of this device
- Jun 24, 2020 · Class II · Z-2746-2020: A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
- Jun 2, 2014 · Class II · Z-2049-2014: Sterility of device is compromised due to breach in sterile barrier
- Jun 2, 2014 · Class II · Z-2047-2014: Sterility of device is compromised due to breach in sterile barrier
- Jun 2, 2014 · Class II · Z-2046-2014: Sterility of device is compromised due to breach in sterile barrier
- Jun 2, 2014 · Class II · Z-2048-2014: Sterility of device is compromised due to breach in sterile barrier
- Jun 2, 2014 · Class II · Z-2045-2014: Sterility of device is compromised due to breach in sterile barrier

## Indications for use
The Smith &Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications: Hip Hip capsule repair (Acetabular labrum repair/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 repair/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/K122059
Methodology: https://510kreport.com/methodology