510(k) · Cleared
ClearedAEVUMED PHANTOM 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 May 31, 2018 as substantially equivalent to K061665 (Arthrex, Inc., 2006) after a 99-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- May 31, 2018
- Review
- 99 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990987 (2000). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
- 2 generations backK043337 Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004
- 1 generation backK061665 Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006
- This deviceK180464 AEVUMED PHANTOM Suture AnchorsAevumed, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK260004 Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK252635 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK262809 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- Descendant · cites it directly · 0 of its ownK254306 Aevumed FENIX Suture AnchorAevumed, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K260004Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026 · cites it directly2descendants
- K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · 2 generations on1descendant
- K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · 3 generations on0descendants
- K254306Aevumed FENIX Suture AnchorAevumed, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990987 | Bio-Absorbable Corkscrew, Model AR-1920B | Arthrex, Inc. | 2000 | — |
| −2 | K043337 | Arthrex Bio-Corkscrew FT Suture Anchor | Arthrex, Inc. | 2004 | — |
| −1 | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K180464 | AEVUMED PHANTOM Suture Anchors | Aevumed, Inc. | 2018 | — |
| +1 | K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026 | — |
| +2 | K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
| +3 | K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
| +1 | K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTSummary page 4…fied as CLASSIFICATION: Class II, product code MBI, Regulation 21 CFR 888.3040 . PREDICATE DEVICE: Arthrex Corkscrew FT, 510(k) number K061665. DEVICE DESCRIPTION: The Aevumed PHANTOMTM Anchor with HS FiberTM suture is a threaded… | 2006 |
What descends from it? (4)
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 18 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K260004 (Aevumed, Inc., 2026) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K061665.
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. 2018, 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 PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures: • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. • Foot/Ankle: Lateral Stabilization, Medial…
Read the full statement (120 words)
The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures:
• Shoulder: Rotator Cuff Repair, Bankart 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.
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180464: AEVUMED PHANTOM Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180464
Report an extraction error
Are you the manufacturer?
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