510(k) Report

510(k) · Cleared

Cleared

Arthrex Short Suture Anchors

K151092510(k) TraditionalCleared Feb 23, 2016306-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

Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Feb 23, 2016 as substantially equivalent to K140855 (Arthrex, Inc., 2014) after a 306-day review. Its family tree reaches back 8 generations to 1996. 12 later devices descend from it.

Decided
Feb 23, 2016
Review
306 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K961555 (1996). 12 ancestors in all. 12 later devices descend from it, 5 citing it directly.

  1. Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 5 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
  5. 4 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
  6. 3 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
  7. 2 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
  8. 1 generation backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
  9. This deviceK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
  10. Descendant · cites it directly · 5 of its ownK201786 Arthrex Mini Hip PushLockArthrex, Inc. · 2020
  11. Descendant · cites it directly · 2 of its ownK251145 Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
  12. Descendant · cites it directly · 2 of its ownK232683 Knotilus+ PEEK Knotless AnchorStryker Endoscopy · 2023
  13. Descendant · 2 generations on · 1 of its ownK253931 Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  14. Descendant · 2 generations on · 1 of its ownK252664 GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2020: 12021: 12023: 12024: 12025: 42026: 4
2020high 4 (2025) · low 0 (2022)2026

Most influential descendants

Showing 5 of 12 · See all
  • K201786Arthrex Mini Hip PushLockArthrex, Inc. · 2020 · cites it directly5descendants
  • K251145Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025 · cites it directly2descendants
  • K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy · 2023 · cites it directly2descendants
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026 · 2 generations on1descendant
  • K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−7K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−6K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−5K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006—
−4K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…Arthrex, Inc.2007—
−3K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009—
−2K110660Arthrex Biocomposite SuturetakArthrex, Inc.2011—
−1K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.2014—
0 (this device)K151092Arthrex Short Suture AnchorsArthrex, Inc.2016—
+1K201786Arthrex Mini Hip PushLockArthrex, Inc.2020—
+1K251145Arthrex PushLock Suture AnchorsArthrex, Inc.2025—
+1K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy2023—
+2K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.2026—
+2K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200510
200610
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
202310
202410
202540
202640
FIG. 1 — Lineage of K151092, 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 MBI? 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 MBI device

  1. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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
*K140855Arthrex Suturetak Suture Anchors
Summary page 4
…1 CFR 888.3040: Smooth or threaded metallic bone fixation fastener CFR Predicate Device K140855: Arthrex SutureTak Suture Anchors Reference Predicate Device K110473: Pivot Nanotak Suture Anchor Purpose of S…
Arthrex, Inc.2014—
†K110473Nanotack Suture Anchor 1.4MMPivot Medical2011—

Also cleared against K140855: 9 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K201786Arthrex Mini Hip PushLockArthrex, Inc.20205
K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252
K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232
K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250
K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250

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 20 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K201786 (Arthrex, Inc., 2020) has gone furthest, with 5 descendants of its own.
  • 9 other devices also cite its predicate K140855.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Arthrex Short Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K151092: Arthrex Short Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151092

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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