510(k) · Cleared
ClearedPhasix Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · OOD Surgical Film
Cleared on Sep 29, 2016 as substantially equivalent to K142818 (C. R. Bard, 2015) after a 129-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 29, 2016
- Review
- 129 days
- Class
- Class II
- Product code
- OOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002699 (2001). 13 ancestors in all, the oldest K810428 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 4 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- 3 generations backK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- 2 generations backK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- 1 generation backK142818 Phasix MeshC. R. Bard · 2015
- This deviceK161424 Phasix MeshC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK191749 TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 2020
- Descendant · 2 generations on · 0 of its ownK233661 Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −4 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| −3 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| −2 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| −1 | K142818 | Phasix Mesh | C. R. Bard | 2015 | — |
| 0 (this device) | K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016 | — |
| +1 | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020 | — |
| +2 | K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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 OOD? 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 OOD device
- #1 K233999 GalaFLEX LITE Scaffoldscore 7.1 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K142818 | Phasix MeshSummary page 4…Name: Surgical Film (21 CFR § 878.3300) Regulatory Class: Class II Product Code: OOD III. PREDICATE DEVICE Phasix™ Mesh cleared in K142818 on March 31, 2015. IV. DEVICE DESCRIPTION The proposed Phasix™ Mesh utilizes a fully resorbable poly-4-hydroxybutyrate (P… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | 2020 | 1 |
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 15 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K191749 (Novus Scientific AB, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OOD devicesOOD Surgical Film: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OOD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OOD
Too few OOD 510(k)s in any year since 2007 to give a median.
Recalls per year · OOD
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOD
111in 2025
MAUDE reports naming product code OOD, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 1 | 9 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 71 |
| 2021 | 1 | — | 0 | 98 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 0 | 126 |
| 2024 | 1 | — | 0 | 196 |
| 2025 | 0 | — | 0 | 111 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161424: Phasix Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161424
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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