510(k) Report

510(k) · Cleared

Cleared

Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor

K053344510(k) TraditionalCleared Feb 23, 200683-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 Feb 23, 2006 as substantially equivalent to K972326 (Orthopaedic Biosystems, Ltd., 1998) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1996. 477 later devices descend from it.

Decided
Feb 23, 2006
Review
83 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K961555 (1996). 3 ancestors in all. 477 later devices descend from it, 16 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2010: 14 descendants cleared2007: 10 descendants cleared2008: 7 descendants cleared2006: 2 descendants cleared2013: 28 descendants cleared2011: 27 descendants cleared2012: 16 descendants cleared2009: 14 descendants cleared2022: 22 descendants cleared2014: 30 descendants cleared2019: 26 descendants cleared2017: 19 descendants cleared2015: 21 descendants cleared2023: 50 descendants cleared2025: 33 descendants cleared2020: 38 descendants cleared2016: 14 descendants cleared2018: 23 descendants cleared2026: 32 descendants cleared2021: 22 descendants cleared2024: 29 descendants clearedK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 16 descendants2 generations forward: 67 descendants3 generations forward: 133 descendants4 generations forward: 127 descendants5 generations forward: 78 descendants6 generations forward: 36 descendants7 generations forward: 15 descendants8 generations forward: 5 descendants K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 19960+5
  1. Root · 2 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 1 generation backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. This deviceK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. Descendant · cites it directly · 283 of its ownK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
  5. Descendant · 2 generations on · 227 of its ownK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
  6. Descendant · cites it directly · 162 of its ownK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  7. Descendant · 3 generations on · 159 of its ownK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
  8. Descendant · cites it directly · 142 of its ownK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007

Showing 5 of 477 descendants. See all descendants

Descendants cleared per year

2006: 22007: 102008: 72009: 142010: 142011: 272012: 162013: 282014: 302015: 212016: 142017: 192018: 232019: 262020: 382021: 222022: 222023: 502024: 292025: 332026: 32
2006high 50 (2023) · low 2 (2006)2026

Most influential descendants

Showing 5 of 477 · See all
  • K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006 · cites it directly283descendants
  • K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2007 · 2 generations on227descendants
  • K061154Kinsa Suture AnchorSmith & Nephew, Inc. · 2006 · cites it directly162descendants
  • K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2009 · 3 generations on159descendants
  • K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007 · cites it directly142descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−1K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
0 (this device)K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
+1K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006—
+2K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…Arthrex, Inc.2007—
+1K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
+3K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock…Arthrex, Inc.2009—
+1K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
2007100
200870
2009140
2010140
2011270
2012160
2013280
2014300
2015210
2016140
2017190
2018230
2019260
2020380
2021220
2022220
2023500
2024290
2025330
2026320
FIG. 1 — Lineage of K053344, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K972326Peba Anchor/Suture Combination
Summary page 1
…e currently marketed ~ndications for use of the following legally marketed devices in commercial distribution: The Smith & Nephew TwinFix Ti 2.8 & 3.5 (K972326) BioRapto: 2.9 (K031683). N<…
Orthopaedic Biosystems, Ltd.19981
*K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318
Our reading of the summary gave K031683, FDA’s number for Tox Ammonia Calibrator (Bayer Healthcare, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioRaptor 2.9”.
Smith & Nephew, Inc.20035

Also cleared against K972326: 8 other devices →

What descends from it? (477)

See all 477

16 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006283
K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006162
K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142
K063726PLC Suture AnchorSmith & Nephew Inc., Endoscopy Div.2007122
K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division200846
K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229
K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077
K091870Tornier, Piton Fixation Implant SystemTornier20096
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20086
K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105

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 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K061863 (Arthrex, Inc., 2006) has gone furthest, with 283 descendants of its own.
  • 8 other devices also cite its predicate K972326.

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 BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis Foot and Ankle Hallux valgus repairs…

Read the full statement (121 words)

The Smith & Nephew BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Capsular Stabilization

Bankhart Repair

Anterior Shoulder Instability Repair

SLAP lesion repairs

Capsular Shift or capsulolabral reconstructions

Acromioclavicular separation repairs

Deltoid Repairs

Rotator Cuff tear repairs

Biceps tenodesis

Foot and Ankle

Hallux valgus repairs

Medial or lateral instablility repairs/reconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Bunionectomy

Elbow

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Biceps tendon reattachment

Knee

Extra-capsular repairs:

medial collateral ligament

lateral collateral ligament

posterior oblique ligament

Patellar realignment and tendon repairs:

vastus medialis obliquous advancement

Iliotibial band tenodesis

Hip

Capsular repair

Acetabular labral repair

Indications for use as stated in the FDA summary.

Also cleared against K972326

8 other devices cite the same predicate.

  • K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T…Smith & Nephew, Inc. · 20152 recalls
  • K123425Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SLSmith & Nephew, Inc. · 2013
  • K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 20104 recalls
  • K083151Extremity Medical Suture AnchorExtremity Medical, LLC · 2009
  • K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  • K020159Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc. · 2002

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/K053344 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053344

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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