510(k) · Cleared
Recalled · Class II · 2024Rotation Medical Soft Tissue Staple (RMST Staple)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rotation Medical, Inc. · GDW Staple, Implantable
Cleared on Jul 12, 2013 as substantially equivalent to K093845 (ETHICON, Inc., 2010) after a 38-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 12, 2013
- Review
- 38 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951658 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
- 4 generations backK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
- 3 generations backK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
- 2 generations backK091900 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009
- 1 generation backK093845 Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model…ETHICON, Inc. · 2010 · Recalled
- This deviceK131637 Rotation Medical Soft Tissue Staple (RMST Staple)Rotation Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK222487 Anika Tissue Tack Fixation SystemAnika Therapeutics, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222487Anika Tissue Tack Fixation SystemAnika Therapeutics, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951658 | Lactosorb Pop Rivet | Poly-Medics,Inc. | 1995 | — |
| −4 | K961585 | Surgical Dynamics Pop Rivet | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −3 | K071920 | Autosuture Absorbable Tack and Applicator | United States Surgical, A Division of Tyco Healthc | 2007 | — |
| −2 | K091900 | Absorbatack 5MM Single Use Absorbable Fixation Device | Covidien Lp, Formerly Registered AS United States | 2009 | — |
| −1 | K093845 | Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25 | ETHICON, Inc. | 2010 | 1 |
| 0 (this device) | K131637 | Rotation Medical Soft Tissue Staple (RMST Staple) | Rotation Medical, Inc. | 2013 | — |
| +1 | K222487 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 GDW? 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 GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 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 |
|---|---|---|---|
| * | K093845 | Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25Summary page 1…Equivalence is Claimed Predicate Device(s): Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device, K093845; Ethicon, Inc. Description of the Device RMST Staple Is an absorbable polymer strap with cleat tips. RMST Staple iscomposed of… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222487 | Anika Tissue Tack Fixation System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2024 | Class II | Z-3097-2024 | Packaging | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| Aug 12, 2024 | Class II | Z-3096-2024 | Packaging | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K222487 (Anika Therapeutics, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K093845.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, 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 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131637: Rotation Medical Soft Tissue Staple (RMST Staple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131637
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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