# K023021: Modification to Smith & Nephew Twinfix TI Quick T

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 4, 2002 after 23 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 2 generations back to K941364 (1994). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020159: Smith & Nephew Twinfix TI Quick T, Smith & Nephew, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K251627: BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) (2025), 0 descendants of its own
- K242477: Shoulder Soft Tissue Anchors (2025), 0 descendants of its own
- K243665: Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (2025), 0 descendants of its own
- K232725: Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (2023), 0 descendants of its own

## Indications for use
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle: Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand: Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment. Knee: Extra-capsular repairs: medial collateral ligament, lateral collateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

Source page: https://510kreport.com/device/K023021
Methodology: https://510kreport.com/methodology