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
C.R. Bard, Inc. · GDW Staple, Implantable
Cleared on May 31, 2017 as substantially equivalent to K142873 (C.R. Bard, Inc., 2015) and 1 other predicate after a 121-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- May 31, 2017
- Review
- 121 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K913469 (1991). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
- 5 generations backK032093 PariefixSofradim Production · 2003
- 4 generations backK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
- 3 generations backK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
- 2 generations backK132134 Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013
- 1 generation backK142873 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable…C.R. Bard, Inc. · 2015
- This deviceK170278 OptiFix AT Absorbable Fixation System with Articulating Technology -…C.R. Bard, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK191287 OptiFix AT Absorbable Fixation System with Articulating Technology –…Davol Inc., Subsidiary of C.R. Bard · 2019
Most influential descendants
Showing 1 of 1 · See all- K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners…Davol Inc., Subsidiary of C.R. Bard · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913469 | Endopath Disposable Endoscopic Multifeed Stapler | ETHICON, Inc. | 1991 | — |
| −5 | K032093 | Pariefix | Sofradim Production | 2003 | — |
| −4 | K060494 | Easytac Anchor. Easytac Delivery System | Medchannel, LLC | 2006 | — |
| −3 | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084… | C.R. Bard, Inc. | 2009 | — |
| −2 | K132134 | Optifix Absorbable Fixation System | C.R. Bard, Inc. | 2013 | — |
| −1 | K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners… | C.R. Bard, Inc. | 2015 | — |
| 0 (this device) | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30… | C.R. Bard, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 15.1 · 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? (2)
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 |
|---|---|---|---|
| * | K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…Summary page 4…egulatory Class: II Product Code: GDW III. PREDICATE DEVICE The primary predicate device for this submission is the OptiFix™Absorbable Fixation System (K142873), cleared March 12, 2015; marketed by Davol, Inc. The primary predicate, hereinafter referred to as “the predicate” throughout t… | 2015 |
| * | K123109 | Absorbatack 5MM Single Use Absorbable Fixation DeviceSummary page 4…as not been subject to a design-related recall. The secondary predicate device for this submission is the Medtronic Covidien AbsorbaTack™ Absorbable Fastener System (K123109), cleared January 27, 2012. K17027… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners… | 2019 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K191287 (Davol Inc., Subsidiary of C.R. Bard, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142873.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 as stated in the FDA summary.
https://510kreport.com/device/K170278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170278: 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 5, 2026. https://510kreport.com/device/K170278
Report an extraction error
Are you the manufacturer?
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