510(k) · Cleared
ClearedAevumed RAPID Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aevumed, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 17, 2023 as substantially equivalent to K140855 (Arthrex, Inc., 2014) after an 80-day review. Its family tree reaches back 8 generations to 1996. 6 later devices descend from it.
- Decided
- Mar 17, 2023
- Review
- 80 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. 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 4 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 3 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 2 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 1 generation backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- This deviceK223878 Aevumed RAPID Suture AnchorsAevumed, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK242895 Aevumed PHANTOM Suture AnchorsAevumed, Inc. · 2025
- Descendant · 2 generations on · 3 of its ownK253040 Aevumed FASE Suture AnchorAevumed, Inc. · 2025
- Descendant · 3 generations on · 2 of its ownK260004 Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026
- Descendant · 4 generations on · 1 of its ownK252635 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- Descendant · 5 generations on · 0 of its ownK262809 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc. · 2025 · cites it directly4descendants
- K253040Aevumed FASE Suture AnchorAevumed, Inc. · 2025 · 2 generations on3descendants
- K260004Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026 · 3 generations on2descendants
- K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · 4 generations on1descendant
- K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −4 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −3 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −2 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −1 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| 0 (this device) | K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | 2023 | — |
| +1 | K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 2025 | — |
| +2 | K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 2025 | — |
| +3 | K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026 | — |
| +4 | K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
| +5 | K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
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 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140855 | Arthrex Suturetak Suture AnchorsSummary page 4…fied as CLASSIFICATION: Class II, product code MBI, Regulation 21 CFR 888.3040 PRIMARY PREDICATE DEVICE: SutureTakTM Suture Anchor, 510(k) number K140855 REFERENCE PREDICATE DEVICE: Aevumed RAPIDTM Suture Anchor, 510(k) number K180464 DEVICE DESCRIPTION: The Ae… | 2014 |
| † | K180464 | AEVUMED PHANTOM Suture Anchors | 2018 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K242895 (Aevumed, Inc., 2025) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K140855.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Aevumed RAPID™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair…
Read the full statement (136 words)
The Aevumed RAPID™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral Repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223878: Aevumed RAPID 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/K223878
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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