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 · GDW Staple, Implantable
Cleared on Oct 23, 2012 as substantially equivalent to K090470 (Covidien, 2009) after a 19-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 23, 2012
- Review
- 19 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951658 (1995). 7 ancestors in all, the oldest K944415 (1994). 4 later devices descend from it, 2 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 backK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
- This deviceK123109 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012
- Descendant · cites it directly · 1 of its ownK170278 OptiFix AT Absorbable Fixation System with Articulating Technology -…C.R. Bard, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK140609 Reliatack Articulating Reloadable Fixation Device with Standard…Covidien · 2014
- Descendant · 2 generations on · 0 of its ownK191287 OptiFix AT Absorbable Fixation System with Articulating Technology –…Davol Inc., Subsidiary of C.R. Bard · 2019
- Descendant · 2 generations on · 0 of its ownK151659 ReliaTack Articulating Reloadable Fixation Device with Deep Purchase…Covidien, LLC · 2015
Most influential descendants
Showing 4 of 4 · See all- K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…C.R. Bard, Inc. · 2017 · cites it directly1descendant
- K140609Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble TacksCovidien · 2014 · cites it directly1descendant
- K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners…Davol Inc., Subsidiary of C.R. Bard · 2019 · 2 generations on0descendants
- K151659ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable TacksCovidien, LLC · 2015 · 2 generations on0descendants
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 | K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation Devices | Covidien | 2009 | 2 |
| 0 (this device) | K123109 | Absorbatack 5MM Single Use Absorbable Fixation Device | Covidien | 2012 | — |
| +1 | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30… | C.R. Bard, Inc. | 2017 | — |
| +1 | K140609 | Reliatack Articulating Reloadable Fixation Device with Standard Purchase… | Covidien | 2014 | — |
| +2 | K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology – 30… | Davol Inc., Subsidiary of C.R. Bard | 2019 | — |
| +2 | K151659 | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase… | Covidien, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation DevicesSummary page 1…nges in the indications or intended use of the device. Predicate Device(s): AbsorbaTack TM Absorbable Fixation Device (K090470) Device description: - Absorba-rackm Absorbable Fixation Devices are steril… | 2009 |
What descends from it? (4)
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 3 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K170278 (C.R. Bard, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K090470.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/K123109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123109: 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/K123109
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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