510(k) Report

510(k) · Cleared

Cleared

Acumed Suture Anchor System

K140925510(k) SpecialCleared May 20, 201439-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

Acumed, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on May 20, 2014 as substantially equivalent to K133469 (Acumed, LLC, 2014) after a 39-day review. Its family tree reaches back 5 generations to 1996.

Decided
May 20, 2014
Review
39 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K961555 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K061863 · Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family · Arthrex, Inc. · 2006K133469 · Acumed Suture Anchor System · Acumed, LLC · 201419952000200520102015
Other ancestors, by generation 4 generations back: 1 other ancestor K133469 · Acumed Suture Anchor System · Acumed, LLC · 2014K061863 · Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family · Arthrex, 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
  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 backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
  5. 1 generation backK133469 Acumed Suture Anchor SystemAcumed, LLC · 2014
  6. This deviceK140925 Acumed Suture Anchor SystemAcumed, LLC · 2014
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—
−2K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006—
−1K133469Acumed Suture Anchor SystemAcumed, LLC2014—
0 (this device)K140925Acumed Suture Anchor SystemAcumed, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K140925, 1996–2014Source: 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
*K133469Acumed Suture Anchor System
Summary page 2
…escribed in ASTM F2026 and UIHMWPE (High-strength suture). Predicate Device: A modification comparison of the proposed Suture Anchors and the predicate Suture Anchors (K 133469) is provided in below Table: K133469 Parts Core Diameter Outside Diameter Description 55…
Acumed, LLC2014—

Also cleared against K133469: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 1 other device also cites its predicate K133469.

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. 2014, 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 Acumed Soft Tissue Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Shoulder: Rotator Cuff Repair, Bankhart Repair, SLAP Lesion Repair, Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization. Medial Stabilization, Achilles Tendon Repair, Hallux Valgus…

Read the full statement (119 words)

The Acumed Soft Tissue Anchor System is intended to be used for suture (soft tissue)

fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart Repair, SLAP Lesion Repair, Biceps Tenodesis.

Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral

Reconstruction.

Foot/Ankle: Lateral Stabilization. Medial Stabilization, Achilles Tendon Repair, Hallux

Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon

Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral

Collateral Ligament Repair, Patellar Tendon Repair. Posterior Oblique Ligament Repair

and liliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral

Ligament Reconstruction.

Elbow: Biceps Tendon Rcattachment, Tennis Elbow Repair, Ulnar or Radial Collateral

Ligament Reconstruction, Lateral Epicondylitis repair.

Indications for use as stated in the FDA summary.

Also cleared against K133469

1 other device cites the same predicate.

  • K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC · 2022

More from Acumed, LLC

38 FDA decisions under this applicant name. See the company

  • K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC · 2025
  • K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC · 20251 recall
  • K251296The Acumed Wrist Fixation SystemAcumed, LLC · 20251 recall
  • K243624Acu-Sinch Knotless MiniAcumed, LLC · 2025
  • K233311Acumed Wrist Plating SystemAcumed, LLC · 2024

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K140925 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140925: Acumed Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140925

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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