510(k) · Cleared
ClearedOptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable 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 Mar 12, 2015 as substantially equivalent to K132134 (C.R. Bard, Inc., 2013) after a 162-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it.
- Decided
- Mar 12, 2015
- Review
- 162 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913469 (1991). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
- 4 generations backK032093 PariefixSofradim Production · 2003
- 3 generations backK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
- 2 generations backK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
- 1 generation backK132134 Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013
- This deviceK142873 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable…C.R. Bard, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK170278 OptiFix AT Absorbable Fixation System with Articulating Technology -…C.R. Bard, Inc. · 2017
- 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 · cites it directly · 0 of its ownK163698 OptiFix Open Absorbable Fixation System - 20 absorbable fastenersC.R. Bard, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…C.R. Bard, Inc. · 2017 · cites it directly1descendant
- K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners…Davol Inc., Subsidiary of C.R. Bard · 2019 · 2 generations on0descendants
- K163698OptiFix Open Absorbable Fixation System - 20 absorbable fastenersC.R. Bard, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913469 | Endopath Disposable Endoscopic Multifeed Stapler | ETHICON, Inc. | 1991 | — |
| −4 | K032093 | Pariefix | Sofradim Production | 2003 | — |
| −3 | K060494 | Easytac Anchor. Easytac Delivery System | Medchannel, LLC | 2006 | — |
| −2 | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084… | C.R. Bard, Inc. | 2009 | — |
| −1 | K132134 | Optifix Absorbable Fixation System | C.R. Bard, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +2 | K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology – 30… | Davol Inc., Subsidiary of C.R. Bard | 2019 | — |
| +1 | K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners | C.R. Bard, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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 15.1 · 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? (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 |
|---|---|---|---|
| * | K132134 | Optifix Absorbable Fixation SystemSummary page 4…cation Name: Implantable staple (21 CFR §878.4750) Regulatory Class: II Product Code: GDW III. PREDICATE DEVICE OptiFix™ Absorbable Fastener System, K132134; marketed by Davol, Inc., This predicate has not been subject to a design-related recall. The reference device Davol Absor… | 2013 |
| † | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086… | 2009 |
What descends from it? (3)
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 24 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K170278 (C.R. Bard, Inc., 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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™ Absorbable Fixation System 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/K142873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142873: OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142873
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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