510(k) · Cleared
ClearedOptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol Inc., Subsidiary of C.R. Bard · GDW Staple, Implantable
Cleared on Jul 16, 2019 as substantially equivalent to K170278 (C.R. Bard, Inc., 2017) after a 64-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jul 16, 2019
- Review
- 64 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913469 (1991). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
- 6 generations backK032093 PariefixSofradim Production · 2003
- 5 generations backK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
- 4 generations backK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
- 3 generations backK132134 Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013
- 2 generations backK142873 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable…C.R. Bard, Inc. · 2015
- 1 generation backK170278 OptiFix AT Absorbable Fixation System with Articulating Technology -…C.R. Bard, Inc. · 2017
- This deviceK191287 OptiFix AT Absorbable Fixation System with Articulating Technology –…Davol Inc., Subsidiary of C.R. Bard · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913469 | Endopath Disposable Endoscopic Multifeed Stapler | ETHICON, Inc. | 1991 | — |
| −6 | K032093 | Pariefix | Sofradim Production | 2003 | — |
| −5 | K060494 | Easytac Anchor. Easytac Delivery System | Medchannel, LLC | 2006 | — |
| −4 | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084… | C.R. Bard, Inc. | 2009 | — |
| −3 | K132134 | Optifix Absorbable Fixation System | C.R. Bard, Inc. | 2013 | — |
| −2 | K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners… | C.R. Bard, Inc. | 2015 | — |
| −1 | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30… | C.R. Bard, Inc. | 2017 | — |
| 0 (this device) | K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology – 30… | Davol Inc., Subsidiary of C.R. Bard | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…Summary page 4…ry Class: I Product Code: GDW HI. PREDICATE DEVICE The predicate device for this submission is the OptiFix™ AT Absorbable Fixation System with Articulating Technology (K170278) cleared May 31, 2017. The predicate device has not been previously released to market and has not been subject to a design-relat… | 2017 |
| † | K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix… | 2015 |
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 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 16 ancestors have a recall of any class.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 OptiFix AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
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/K191287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191287: OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191287
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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