# K093228: Smith & Nephew Twinfix Ultra PK Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 15, 2009 after 61 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: 6 generations back to K961555 (1996). 8 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072785: Twinfix FT PK, Smith & Nephew Inc., Endoscopy Division (2007). Our reading of the summary gave K072875, FDA’s number for Nio 5MP Display, Model E5620 (Barcoview, Medical Imaging Systems). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Smith & Nephew TWINFIX PK FT Suture Anchor”.

## Most influential descendants
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor (2010), 17 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
- K222763: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (2022), 1 descendant of its own

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

Source page: https://510kreport.com/device/K093228
Methodology: https://510kreport.com/methodology