510(k) · Cleared
ClearedAbsorbatack 5MM Single Use Absorbable Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS United States · GDW Staple, Implantable
Cleared on Jul 16, 2009 as substantially equivalent to K071920 (United States Surgical, A Division of Tyco Healthc, 2007) after a 21-day review. Its family tree reaches back 3 generations to 1995. 12 later devices descend from it.
- Decided
- Jul 16, 2009
- Review
- 21 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951658 (1995). 4 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
- 2 generations backK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
- 1 generation backK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
- This deviceK091900 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009
- Descendant · cites it directly · 11 of its ownK093845 Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model…ETHICON, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK132698 Fastouch Fixation SystemVia Surgical, Ltd. · 2014
- Descendant · 2 generations on · 3 of its ownK131635 Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK162252 FasTouch Fixation SystemVia Surgical, Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK223860 Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc. · 2010 · cites it directly11descendants
- K132698Fastouch Fixation SystemVia Surgical, Ltd. · 2014 · 2 generations on3descendants
- K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc. · 2013 · 2 generations on3descendants
- K162252FasTouch Fixation SystemVia Surgical, Ltd. · 2016 · 3 generations on2descendants
- K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951658 | Lactosorb Pop Rivet | Poly-Medics,Inc. | 1995 | — |
| −2 | K961585 | Surgical Dynamics Pop Rivet | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −1 | K071920 | Autosuture Absorbable Tack and Applicator | United States Surgical, A Division of Tyco Healthc | 2007 | — |
| 0 (this device) | 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 |
| +2 | K132698 | Fastouch Fixation System | Via Surgical, Ltd. | 2014 | — |
| +2 | K131635 | Rotation Medical Bone Staple (RMB Staple) | Rotation Medical, Inc. | 2013 | — |
| +3 | K162252 | FasTouch Fixation System | Via Surgical, Ltd. | 2016 | — |
| +3 | K223860 | Integrity™ Bone Staple 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 15.0 · 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 |
|---|---|---|---|
| * | K071920 | Autosuture Absorbable Tack and ApplicatorSummary page 1…Absorbable Tack and Applicator CLASSIFICATION NAME: Implantable Staple PREDICATE DEVICE(S): K071 920 - AbsorbatackTm Absorbable Fixation Note: There are no modifications Device to the previously clear… | 2007 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093845 | Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25 | 2010 | 11 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K093845 (ETHICON, Inc., 2010) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K071920.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 device is intended for fixation of prosthetic material to soft tissue 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/K091900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091900: Absorbatack 5MM Single Use Absorbable Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091900
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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