510(k) · Cleared
ClearedOptifix Absorbable Fixation System
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 Dec 2, 2013 as substantially equivalent to K082396 (C.R. Bard, Inc., 2009) after a 144-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it.
- Decided
- Dec 2, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913469 (1991). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
- 3 generations backK032093 PariefixSofradim Production · 2003
- 2 generations backK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
- 1 generation backK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
- This deviceK132134 Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK142873 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable…C.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK170278 OptiFix AT Absorbable Fixation System with Articulating Technology -…C.R. Bard, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK191287 OptiFix AT Absorbable Fixation System with Articulating Technology –…Davol Inc., Subsidiary of C.R. Bard · 2019
- Descendant · 2 generations on · 0 of its ownK163698 OptiFix Open Absorbable Fixation System - 20 absorbable fastenersC.R. Bard, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…C.R. Bard, Inc. · 2015 · cites it directly3descendants
- K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…C.R. Bard, Inc. · 2017 · 2 generations on1descendant
- K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners…Davol Inc., Subsidiary of C.R. Bard · 2019 · 3 generations on0descendants
- K163698OptiFix Open Absorbable Fixation System - 20 absorbable fastenersC.R. Bard, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913469 | Endopath Disposable Endoscopic Multifeed Stapler | ETHICON, Inc. | 1991 | — |
| −3 | K032093 | Pariefix | Sofradim Production | 2003 | — |
| −2 | K060494 | Easytac Anchor. Easytac Delivery System | Medchannel, LLC | 2006 | — |
| −1 | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084… | C.R. Bard, Inc. | 2009 | — |
| 0 (this device) | 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 | — |
| +2 | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30… | C.R. Bard, Inc. | 2017 | — |
| +3 | K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology – 30… | Davol Inc., Subsidiary of C.R. Bard | 2019 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086…Summary page 1…Staple Implantable/Implantable Staple Name Regulatory Class Class II per 21 CFR §878.4750 Product Code GOW Legally Marketed K082396 Davol Absorbable Fastener System- SorbaFixTM - 02Jan2009 Predicate Device(s) Device Description The OPTIFIXTm Absorb… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix… | 2015 | 3 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K142873 (C.R. Bard, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K082396.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 OPTIFIXIN 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/K132134 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132134: Optifix Absorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132134
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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