510(k) · Cleared
ClearedRotation Medical Bone Staple (RMB Staple)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rotation Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 29, 2013 as substantially equivalent to K093845 (ETHICON, Inc., 2010) and 1 other predicate after an 86-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 29, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K961555 (1996). 15 ancestors in all, the oldest K951658 (1995). 3 later devices descend from it, 2 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 backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 1 generation backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- This deviceK131635 Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK223860 Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK261869 Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK213958 Bioabsorbable AnchorEmbody, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc. · 2023 · cites it directly1descendant
- K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026 · 2 generations on0descendants
- K213958Bioabsorbable AnchorEmbody, Inc. · 2022 · cites it directly0descendants
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 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −1 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| 0 (this device) | K131635 | Rotation Medical Bone Staple (RMB Staple) | Rotation Medical, Inc. | 2013 | — |
| +1 | K223860 | Integrity™ Bone Staple Fixation System | Anika Therapeutics, Inc. | 2023 | — |
| +2 | K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | 2026 | — |
| +1 | K213958 | Bioabsorbable Anchor | Embody, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K093845 | Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25Summary page 1…valence is Claimed Predicate Device(s): Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device, K(093845; Ethicon, Inc. Swivel-ock Anchors, K(101823 Arthrex, Inc. Description of the Device… | 2010 |
| * | K101823 | Arthrex Swivelock AnchorsSummary page 1…m Absorbable Strap Fixation Device, K(093845; Ethicon, Inc. Swivel-ock Anchors, K(101823 Arthrex, Inc. Description of the Device The RMB Staple is a sterile, single use polymer strap with cleat tips. RMB Staple is co… | 2011 |
What descends from it? (3)
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 17 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K223860 (Anika Therapeutics, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K093845.
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. 2013, 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 RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131635: Rotation Medical Bone Staple (RMB Staple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131635
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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