510(k) · Cleared
Recalled · 2010Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GDW Staple, Implantable
Cleared on Apr 7, 2010 as substantially equivalent to K091900 (Covidien Lp, Formerly Registered AS United States, 2009) after a 113-day review. Its family tree reaches back 4 generations to 1995. 11 later devices descend from it. It has been recalled once.
- Decided
- Apr 7, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951658 (1995). 5 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
- 3 generations backK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
- 2 generations backK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
- 1 generation backK091900 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009
- This deviceK093845 Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model…ETHICON, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK132698 Fastouch Fixation SystemVia Surgical, Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK131635 Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK162252 FasTouch Fixation SystemVia Surgical, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK223860 Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK181668 FasTouch Absorbable Fixation SystemVia Surgical, Ltd. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132698Fastouch Fixation SystemVia Surgical, Ltd. · 2014 · cites it directly3descendants
- K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc. · 2013 · cites it directly3descendants
- K162252FasTouch Fixation SystemVia Surgical, Ltd. · 2016 · 2 generations on2descendants
- K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc. · 2023 · 2 generations on1descendant
- K181668FasTouch Absorbable Fixation SystemVia Surgical, Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951658 | Lactosorb Pop Rivet | Poly-Medics,Inc. | 1995 | — |
| −3 | K961585 | Surgical Dynamics Pop Rivet | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −2 | K071920 | Autosuture Absorbable Tack and Applicator | United States Surgical, A Division of Tyco Healthc | 2007 | — |
| −1 | K091900 | Absorbatack 5MM Single Use Absorbable Fixation Device | Covidien Lp, Formerly Registered AS United States | 2009 | — |
| 0 (this device) | K093845 | Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25 | ETHICON, Inc. | 2010 | — |
| +1 | K132698 | Fastouch Fixation System | Via Surgical, Ltd. | 2014 | — |
| +1 | K131635 | Rotation Medical Bone Staple (RMB Staple) | Rotation Medical, Inc. | 2013 | — |
| +2 | K162252 | FasTouch Fixation System | Via Surgical, Ltd. | 2016 | — |
| +2 | K223860 | Integrity™ Bone Staple Fixation System | Anika Therapeutics, Inc. | 2023 | — |
| +2 | K181668 | FasTouch Absorbable Fixation System | Via Surgical, Ltd. | 2019 | — |
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 |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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 15.1 · 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 |
|---|---|---|---|
| * | K091900 | Absorbatack 5MM Single Use Absorbable Fixation DeviceSummary page 1…n Device Name: Implantable staple; 2 1CFR 878.4750 Classification: GDW; Class II Predicate Devices: AbsorbaTackTm Absorbable Fixation Device (K09 1900) Manufacturer: Ethicon LLC Guaynabo, Puerto Rico 00969 USA… | 2009 |
What descends from it? (11)
See all 114 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2010 | Not classified | Z-1260-2011 | Pending | The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132698 (Via Surgical, Ltd., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ETHICON SECURESTRAPTM 5mm Absorbable Strap Fixation Device is intended for
fixation of prosthetic material to soft tissues in various minimally invasive and open
surgical procedures such as hernia repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093845: Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093845
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