510(k) · Cleared
ClearedAevumed PROTEKT Suture Anchor
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 Jan 28, 2026 as substantially equivalent to K253040 (Aevumed, Inc., 2025) and 2 other predicates after a 26-day review. Its family tree reaches back 11 generations to 1996. 2 later devices descend from it.
- Decided
- Jan 28, 2026
- Review
- 26 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K961555 (1996). 21 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations between
- 3 generations backK223878 Aevumed RAPID Suture AnchorsAevumed, Inc. · 2023
- 2 generations backK242895 Aevumed PHANTOM Suture AnchorsAevumed, Inc. · 2025
- 1 generation backK253040 Aevumed FASE Suture AnchorAevumed, Inc. · 2025
- This deviceK260004 Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK252635 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK262809 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
Show all 11 generations
- Root · 11 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 10 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 9 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 8 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 7 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 6 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 5 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 4 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 3 generations backK223878 Aevumed RAPID Suture AnchorsAevumed, Inc. · 2023
- 2 generations backK242895 Aevumed PHANTOM Suture AnchorsAevumed, Inc. · 2025
- 1 generation backK253040 Aevumed FASE Suture AnchorAevumed, Inc. · 2025
- This deviceK260004 Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −10 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −9 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −8 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −7 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −6 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −5 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −4 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| −3 | K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | 2023 | — |
| −2 | K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 2025 | — |
| −1 | K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 2025 | — |
| 0 (this device) | K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026 | — |
| +1 | K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
| +2 | K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K253040 | Aevumed FASE Suture AnchorSummary page 5…ners, classified as CLASSIFICATION: Class II, product code: MBI, Regulation 21 CFR 888.3040 PRIMARY PREDICATE Aevumed FASETM Suture Anchor, 510(k) number K253040 DEVICE: ADDITIONAL Aevumed PHANTOMTM-LP Suture Anchor, 510(k) number K222363 PREDICATE DEVICES: Aevumed PHANT… | 2025 |
| * | K222363 | Aevumed PHANTOM™-LP Suture AnchorsSummary page 5…88.3040 PRIMARY PREDICATE Aevumed FASETM Suture Anchor, 510(k) number K253040 DEVICE: ADDITIONAL Aevumed PHANTOMTM-LP Suture Anchor, 510(k) number K222363 PREDICATE DEVICES: Aevumed PHANTOMTM Suture Anchor, 510(k) number K180464 DEVICE DESCRIPTION: The Aevumed PROTEKTTM Su… | 2022 |
| * | K180464 | AEVUMED PHANTOM Suture AnchorsSummary page 5…253040 DEVICE: ADDITIONAL Aevumed PHANTOMTM-LP Suture Anchor, 510(k) number K222363 PREDICATE DEVICES: Aevumed PHANTOMTM Suture Anchor, 510(k) number K180464 DEVICE DESCRIPTION: The Aevumed PROTEKTTM Sutures Anchor with HS FiberTM suture is a suture anchor… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252635 | ArthroTAK Tendon Anchor Kit | 2026 | 1 |
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 30 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K252635 (ArthroTAK, LLC, 2026) has gone furthest, with 1 descendant of its own.
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. 2026, 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 PROTEKT™ 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…
Read the full statement (136 words)
The Aevumed PROTEKT™ 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, lliotibial 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260004: Aevumed PROTEKT Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260004
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