510(k) Report

510(k) · Cleared

Cleared

Modification to Smith & Nephew Twinfix TI Quick T

K023021510(k) SpecialCleared Oct 4, 200223-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · HWC Screw, Fixation, Bone

Cleared on Oct 4, 2002 as substantially equivalent to K020159 (Smith & Nephew, Inc., 2002) after a 23-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.

Decided
Oct 4, 2002
Review
23 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K941364 (1994). 3 ancestors in all. 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2015: 1 descendant cleared2023: 2 descendants cleared2025: 3 descendants cleared2022: 1 descendant clearedK941364 · Acufex T-Fix Rotator Cuff Guide Systems · Acufex Microsurgical, Inc. · 1994K020159 · Smith & Nephew Twinfix TI Quick T · Smith & Nephew, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 6 descendants K020159 · Smith & Nephew Twinfix TI Quick T · Smith & Nephew, Inc. · 2002K941364 · Acufex T-Fix Rotator Cuff Guide Systems · Acufex Microsurgical, Inc. · 19940
  1. Root · 2 generations backK941364 Acufex T-Fix Rotator Cuff Guide SystemsAcufex Microsurgical, Inc. · 1994
  2. 1 generation backK020159 Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc. · 2002
  3. This deviceK023021 Modification to Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc. · 2002
  4. Descendant · cites it directly · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK251627 BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid…Smith & Nephew, Inc. · 2025
  6. Descendant · 2 generations on · 0 of its ownK242477 Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025
  7. Descendant · 2 generations on · 0 of its ownK243665 Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK…ZheJiang Decans Medical Devices Co., Ltd. · 2025
  8. Descendant · 2 generations on · 0 of its ownK232725 Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2015: 12022: 12023: 22025: 3
2015high 3 (2025) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · See all
  • K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · cites it directly6descendants
  • K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc. · 2025 · 2 generations on0descendants
  • K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
  • K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd. · 2025 · 2 generations on0descendants
  • K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K941364Acufex T-Fix Rotator Cuff Guide SystemsAcufex Microsurgical, Inc.1994—
−1K020159Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc.2002—
0 (this device)K023021Modification to Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc.2002—
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…Smith & Nephew, Inc.20152
+2K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)…Smith & Nephew, Inc.2025—
+2K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.2025—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor…ZheJiang Decans Medical Devices Co., Ltd.2025—
+2K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202210
202320
202530
FIG. 1 — Lineage of K023021, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K020159Smith & Nephew Twinfix TI Quick T
Summary page 2
…ith & Nephew TwinFix Ti Quick T is substantially equivalent in design, function, and intended use to the following predicate device: Smith & Nephew TwinFix Ti Quick T, K020159, March 26,2002 William McCalluni Regulutory Specialist (- #I %a+ g< %.a rt.wu,…
Smith & Nephew, Inc.2002—

Also cleared against K020159: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.20156

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?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K152566 (Smith & Nephew, Inc., 2015) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K020159.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

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 as stated in the FDA summary.

Also cleared against K020159

1 other device cites the same predicate.

  • K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix…Depuy Mitek, A Johnson & Johnson Company · 2011

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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The HWC category page

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https://510kreport.com/device/K023021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023021: Modification to Smith & Nephew Twinfix TI Quick T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023021

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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