510(k) · Cleared
ClearedOptiFix Open Absorbable Fixation System - 20 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 Apr 11, 2017 as substantially equivalent to K142873 (C.R. Bard, Inc., 2015) after a 103-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Apr 11, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913469 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK163698 OptiFix Open Absorbable Fixation System - 20 absorbable fastenersC.R. Bard, Inc. · 2017
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) | 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 |
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 |
|---|---|---|---|
| * | K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…Summary page 4…ulatory Class: II Product Code: GDW III. PREDICATE DEVICE The predicate device for this submission is the OptiFix™Absorbable Fixation System (K142873), cleared March 12, 2015; marketed by Davol, Inc. This predicate has not been subject to a design-related recall. The referenc… | 2015 |
| † | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086… | 2009 |
| † | K132134 | Optifix Absorbable Fixation System | 2013 |
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 26 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 8 ancestors has a recall.
- 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™ Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163698 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163698: OptiFix Open Absorbable Fixation System - 20 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/K163698
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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