510(k) · Cleared
ClearedMICRORAPTOR REGENESORB Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith and Nephew, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on May 30, 2018 as substantially equivalent to K101459 (Smith & Nephew, Inc., 2011) and 2 other predicates after a 110-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.
- Decided
- May 30, 2018
- Review
- 110 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K961555 (1996). 15 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 3 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 2 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 1 generation backK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
- This deviceK180361 MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK181746 MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK251809 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK260561 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252314 Arthrex SutureTak Suture AnchorArthrex, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018 · cites it directly3descendants
- K251809Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025 · 2 generations on1descendant
- K260561Arthrex FiberTak Suture AnchorArthrex, Inc. · 2026 · 3 generations on0descendants
- K252314Arthrex SutureTak Suture AnchorArthrex, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −3 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −2 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −1 | K101459 | Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765… | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K180361 | MICRORAPTOR REGENESORB Suture Anchor | Smith and Nephew, Inc. | 2018 | — |
| +1 | K181746 | MICRORAPTOR Knotless Suture Anchor | Smith and Nephew, Inc. | 2018 | — |
| +2 | K251809 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2025 | — |
| +3 | K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026 | — |
| +2 | K252314 | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K101459 | Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Summary page 4…ion Clearance Date Number OSTEORAPTOR OS Suture Anchor K101459 January 27, 2011 OSTEORAPTOR Suture Anchor K082215 November 3, 2008… | 2011 |
| * | K082215 | Osteoraptor Suture AnchorSummary page 4…OSTEORAPTOR OS Suture Anchor K101459 January 27, 2011 OSTEORAPTOR Suture Anchor K082215 November 3, 2008 NANOTACK Suture Anchor, 1.4mm K131769 October 7, 2013… | 2008 |
| * | K131769 | Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMSummary page 4…OSTEORAPTOR Suture Anchor K082215 November 3, 2008 NANOTACK Suture Anchor, 1.4mm K131769 October 7, 2013 Device Description The Smith & Nephew MICRORAPTOR Suture Anchor consists of an ancho… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181746 | MICRORAPTOR Knotless Suture Anchor | 2018 | 3 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 15 ancestors have a recall of any class.
- Of its descendants, K181746 (Smith and Nephew, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K101459.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, 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 · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Smith & Nephew MICRORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip
Acetabular labrum repair/reconstruction
Shoulder
• Capsular stabilization
– Bankart repair
– Anterior shoulder instability
– SLAP lesion repairs
– Capsular shift or capsulolabral reconstructions
• Biceps tenodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180361: MICRORAPTOR REGENESORB 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/K180361
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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