510(k) · Cleared
ClearedSmith & Nephew Twinfix TI Quick T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 26, 2002 as substantially equivalent to K941364 (Acufex Microsurgical, Inc., 1994) and 1 other predicate after a 68-day review. Its family tree reaches back 1 generation to 1994. 24 later devices descend from it.
- Decided
- Mar 26, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941364 (1994). 2 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941364 Acufex T-Fix Rotator Cuff Guide SystemsAcufex Microsurgical, Inc. · 1994
- This deviceK020159 Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · cites it directly · 7 of its ownK023021 Modification to Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly15descendants
- K023021Modification to Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc. · 2002 · cites it directly7descendants
- K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 2 generations on6descendants
- K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · 2 generations on6descendants
- K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941364 | Acufex T-Fix Rotator Cuff Guide Systems | Acufex Microsurgical, Inc. | 1994 | — |
| 0 (this device) | K020159 | Smith & Nephew Twinfix TI Quick T | Smith & Nephew, Inc. | 2002 | — |
| +1 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +1 | K023021 | Modification to Smith & Nephew Twinfix TI Quick T | Smith & Nephew, Inc. | 2002 | — |
| +2 | K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021 | 1 |
| +2 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… | Smith & Nephew, Inc. | 2015 | 2 |
| +2 | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941364 | Acufex T-Fix Rotator Cuff Guide SystemsSummary page 1…T Common Name: Suture Anchor Suture, Nonabsorbable, Polyester Classification Name: Screw, Fixation, Bone D. Predicate Devices Acufex T-Fix Rotator Cuff Guide System, K941364 PEBA Anchor/Suture Combination K972326 E. Description of Device The Smith & Nephew TwinFix Ti Quick T is a sterile single use a… | 1994 |
| * | K972326 | Peba Anchor/Suture CombinationSummary page 1…onabsorbable, Polyester Classification Name: Screw, Fixation, Bone D. Predicate Devices Acufex T-Fix Rotator Cuff Guide System, K941364 PEBA Anchor/Suture Combination K972326 E. Description of Device The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to ancho… | 1998 |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K102298 (Depuy Mitek, A Johnson & Johnson Company, 2011) has gone furthest, with 15 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
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…
Read the full statement (136 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020159 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020159: Smith & Nephew Twinfix TI Quick T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020159
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026