# K032197: Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 8, 2003 after 21 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: 1 generation back to K011299 (2001). 1 ancestor in all.
20 later devices descend from it; 2 cite it directly.
0 of 22 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)

## Most influential descendants
- K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor (2010), 16 descendants of its own
- 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
- K123393: Healicoil Suture Anchor with Regenesorb (2013), 4 descendants of its own

## Indications for use
Shoulder: 1. Bankart Lesion Repair 2. SLAP Lesion Repair 3. Acromioclavicular separation repairs 4. Rotator Cuff Repair 5. Capsular shift or capsulolabral reconstruction 6. Biceps tenodesis 7. Deltoid Repair Foot and Ankle: 1. Hallux Valgus repair 2. Medial or Lateral instability repaidreconstruction 3. Achilles tendon repair/reconstruction 4. Midfoot reconstruction 5. Metatarsal ligament/tendon repairs/reconstruction Elbow, Wrist, and Hand: 1. Scapholunate ligament reconstruction 2. Ulnar or radial collateral ligament reconstruction 3. Lateral epicondylitis repair 4. Biceps tendon reattachment Knee: 1. Extra-capsular Repairs: la. Medial Collateral Repair 1b. Lateral Collateral Ligament IC. Posterior Oblique Ligament 2. Iliotibial band tenodesis 3. Patellar realignment and tendon repairs, including vastus medialis obliquos -advancement

Source page: https://510kreport.com/device/K032197
Methodology: https://510kreport.com/methodology