# K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 1, 2010 after 107 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 13 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011299: Smith and Nephew 5.00MM Absorbable Polymer Anchor, Smith & Nephew, Inc. (2001) Summary page 1.
- K032197: Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212, Smith & Nephew, Inc. (2003) Summary page 1.
- K072785: Twinfix FT PK, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 1.
- K082215: Osteoraptor Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2008) Summary page 1.

## Most influential descendants
- K112526: Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors (2012), 13 descendants of its own
- 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 (2015), 6 descendants of its own
- K180951: Responsive Arthroscopy Suture Anchor System (2019), 4 descendants of its own
- K222763: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (2022), 1 descendant of its own
- K202153: Responsive Arthroscopy Suture Anchor System (2020), 1 descendant of its own

## Recalls of this device
- Aug 6, 2013 · Class II · Z-2237-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2239-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2231-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2238-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2229-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2230-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2232-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2236-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2235-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2233-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2240-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

## Indications for use
The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart repairs SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement fliotibial band tenodesis Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Source page: https://510kreport.com/device/K093844
Methodology: https://510kreport.com/methodology