510(k) Report

510(k) · Cleared

Cleared

Twinfix FT PK

K072785510(k) TraditionalCleared Dec 10, 200770-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., Endoscopy Division · HWC Screw, Fixation, Bone

Cleared on Dec 10, 2007 as substantially equivalent to K070908 (Smith & Nephew Inc., Endoscopy Division, 2007) and 1 other predicate after a 70-day review. Its family tree reaches back 5 generations to 1996. 59 later devices descend from it.

Decided
Dec 10, 2007
Review
70 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K961555 (1996). 7 ancestors in all. 59 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor2010: 4 descendants cleared2009: 2 descendants cleared2015: 4 descendants cleared2011: 1 descendant cleared2016: 2 descendants cleared2023: 9 descendants cleared2012: 2 descendants cleared2014: 2 descendants cleared2025: 8 descendants cleared2022: 5 descendants cleared2020: 4 descendants cleared2013: 1 descendant cleared2019: 1 descendant cleared2024: 5 descendants cleared2017: 4 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2026: 3 descendants clearedK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalled×2: 2 generations cleared close together, K053344 (2006), K061154 (2006) K070908 · Smith & Nephew Kinsa RC Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 20071995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 14 descendants3 generations forward: 14 descendants4 generations forward: 17 descendants5 generations forward: 5 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K070908 · Smith & Nephew Kinsa RC Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007K061154 · Kinsa Suture Anchor · Smith & Nephew, Inc. · 2006K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996−50+5
  1. Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 2 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  5. 1 generation backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
  6. This deviceK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
  7. Descendant · cites it directly · 40 of its ownK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
  8. Descendant · 2 generations on · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
  9. Descendant · cites it directly · 19 of its ownK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
  10. Descendant · 2 generations on · 17 of its ownK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
  11. Descendant · cites it directly · 16 of its ownK093844 Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · Recalled

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2009: 22010: 42011: 12012: 22013: 12014: 22015: 42016: 22017: 42018: 12019: 12020: 42021: 12022: 52023: 92024: 52025: 82026: 3
2009high 9 (2023) · low 1 (2011)2026

Most influential descendants

Showing 5 of 59 · See all
  • K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011 · cites it directly40descendants
  • K133671Iconix All Suture AnchorsStryker Corp. · 2014 · 2 generations on25descendants
  • K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009 · cites it directly19descendants
  • K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · 2 generations on17descendants
  • K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · cites it directly16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−4K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−3K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−2K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
−1K070908Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division2007—
0 (this device)K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division2007—
+1K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.2011—
+2K133671Iconix All Suture AnchorsStryker Corp.2014—
+1K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc.2009—
+2K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div.20104
+1K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.201011

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201040
201110
201220
201310
201420
201540
201620
201740
201810
201910
202040
202110
202250
202390
202450
202580
202630
FIG. 1 — Lineage of K072785, 1996–2026Source: 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? (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
*K070908Smith & Nephew Kinsa RC Suture Anchor
Summary page 1
…Non-degradable, soft tissue D. Predicate Devices The TWINFIX FT PK Suture Anchor is substanlially equivalent to the Smith & Nephew KINSA RC (K070908) and TWINFIX AB (011219). 15 === Pa…
Smith & Nephew Inc., Endoscopy Division2007—
*K011219Ascent Knee System
Summary page 1
…le, soft tissue D. Predicate Devices The TWINFIX FT PK Suture Anchor is substanlially equivalent to the Smith & Nephew KINSA RC (K070908) and TWINFIX AB (011219). 15 E. Description…
Biomet, Inc.2001—

What descends from it? (59)

See all 59

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

NumberDeviceApplicantDecidedDescendants
K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140
K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc.200919
K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.201016
K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097
K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.20156
K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC20161

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 11 years and passes through 3 companies; a new generation was cleared every 11 months on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K110545 (Smith & Nephew, Inc., 2011) has gone furthest, with 40 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Bankhart 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 instability repairs/reconstructions Achilles tendon…

Read the full statement (103 words)

The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Bankhart 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 instability repairs/reconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

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

Indications for use as stated in the FDA summary.

More from Smith & Nephew Inc., Endoscopy Division

8 FDA decisions under this applicant name. See the company

  • K121904Gynecology Sterilization TraySmith & Nephew Inc., Endoscopy Division · 2013
  • K102982Endobutton DirectSmith & Nephew Inc., Endoscopy Division · 2011
  • K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 20089 recalls
  • K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
  • K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 20071 recall

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https://510kreport.com/device/K072785 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072785: Twinfix FT PK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072785

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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