510(k) · Cleared
Recalled · Class II · 2023Autosuture Protack; Tacker System; Absorbatack Fixation Devices
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 May 14, 2009 as substantially equivalent to K963999 (United States Surgical, A Division of Tyco Healthc, 1996) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1995. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- May 14, 2009
- Review
- 80 days
- Class
- Class II
- Product code
- OCW
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K951658 (1995). 6 ancestors in all, the oldest K944415 (1994). 12 later devices descend from it, 6 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 deviceK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009
- Descendant · cites it directly · 4 of its ownK123109 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012
- Descendant · 2 generations on · 1 of its ownK170278 OptiFix AT Absorbable Fixation System with Articulating Technology -…C.R. Bard, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK142808 CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners…C.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK140609 Reliatack Articulating Reloadable Fixation Device with Standard…Covidien · 2014
- Descendant · cites it directly · 1 of its ownK110728 Imesh TackerEasylap, Ltd. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012 · cites it directly4descendants
- K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…C.R. Bard, Inc. · 2017 · 2 generations on1descendant
- K142808CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation…C.R. Bard, Inc. · 2015 · cites it directly1descendant
- K140609Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble TacksCovidien · 2014 · 2 generations on1descendant
- K110728Imesh TackerEasylap, Ltd. · 2011 · cites it directly1descendant
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) | K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation Devices | Covidien | 2009 | — |
| +1 | K123109 | Absorbatack 5MM Single Use Absorbable Fixation Device | Covidien | 2012 | — |
| +2 | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30… | C.R. Bard, Inc. | 2017 | — |
| +1 | K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure… | C.R. Bard, Inc. | 2015 | — |
| +2 | K140609 | Reliatack Articulating Reloadable Fixation Device with Standard Purchase… | Covidien | 2014 | — |
| +1 | K110728 | Imesh Tacker | Easylap, Ltd. | 2011 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 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 12.1 · 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? (3)
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 |
|---|---|---|---|
| * | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** DeviceSummary page 1…Surgical Stapler with Implantable Staple CLASSIFICATION NAME: Staple, Implantable PREDICATE DEVICE(S): Autosuture TT MM Protack TMT M(K963999), Autosuture TACKER System (K944415),… | 1996 |
| * | K944415 | Origin Tacker SystemSummary page 1…Staple, Implantable PREDICATE DEVICE(S): Autosuture TT MM Protack TMT M(K963999), Autosuture TACKER System (K944415), T Absorbatack M Absorbable Fixation Device… | 1994 |
| * | K071920 | Autosuture Absorbable Tack and ApplicatorSummary page 1…e TACKER System (K944415), T Absorbatack M Absorbable Fixation Devices (K071920) DEVICE DESCRIPTION: AutosutureTM ProtackTM: The AutosutureTM Protack 5 mm instrument… | 2007 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123109 | Absorbatack 5MM Single Use Absorbable Fixation Device | 2012 | 4 |
| K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation… | 2015 | 1 |
| K110728 | Imesh Tacker | 2011 | 1 |
| K231240 | MaxTack™ Motorized Fixation Device | 2023 | 0 |
| K130059 | Endofast Reliant SCP, Endofast Reliant Lap | 2013 | 0 |
| K111048 | Synthes Scout Tack Fixation | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2023 | Class II | Z-0986-2024 | Process control | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility |
| Feb 8, 2010 | Not classified | Z-1157-2010 | Process control | Fixation device may fail to fire and staple. |
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 1.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K123109 (Covidien, 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K963999.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
AutosutureTM Protack: The Auto SutureTM ProtackTM 5mm instrument has application in endoscopic surgery procedures for fixation of prosthetic material and approximation of tissue in various surgical specialties, such as the repair of hernial defects.
AutosutureTM TACKER TM System: The Auto Suture TM TACKER TM System is indicated to affix prosthetic material or approximate tissue in a variety of endoscopic or other surgical procedures.
Absorbatack T M Absorbable Fixation Devices: 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/K090470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090470
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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