510(k) · Cleared
ClearedMaxTack™ Motorized Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · OCW Endoscopic Tissue Approximation Device
Cleared on Sep 8, 2023 as substantially equivalent to K090470 (Covidien, 2009) after a 133-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 8, 2023
- Review
- 133 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951658 (1995). 7 ancestors in all, the oldest K944415 (1994). No later device cites it as a predicate yet.
- 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 deviceK231240 MaxTack™ Motorized Fixation DeviceCovidien · 2023
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) | K231240 | MaxTack™ Motorized Fixation Device | Covidien | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 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 5…gy; General and Plastic Surgery Common Name: Surgical Stapler PREDICATE DEVICE: Predicate 510(k) Number K090470 Proprietary/Trade Name AbsorbaTackTM Absorbable Fixation Device (ABSTACK30) Classification Name Endoscopic… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 5 other devices also cite its predicate K090470.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231240: MaxTack™ Motorized 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/K231240
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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