510(k) · Cleared

Cleared

Phasix ST Mesh

K143380510(k) TraditionalCleared Jun 5, 2015192-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · OWT Mesh, Surgical, Absorbable, Abdominal Hernia

Cleared on Jun 5, 2015 as substantially equivalent to K070894 (Tepha, Inc., 2007) and 3 other predicates after a 192-day review. Its family tree reaches back 6 generations to 1997. 4 later devices descend from it.

Decided: Jun 5, 2015
Review: 192 days
Class: Class II
Product code: OWT
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K971745 (1997). 20 ancestors in all, the oldest K810428 (1981). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
5 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
4 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
3 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
2 generations backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
1 generation backK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · Recalled
This deviceK143380 Phasix ST MeshC.R. Bard, Inc. · 2015
Descendant · cites it directly · 1 of its ownK173143 Phasix ST MeshC.R. Bard, Inc. · 2018
Descendant · cites it directly · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
Descendant · 2 generations on · 0 of its ownK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
Descendant · 2 generations on · 0 of its ownK182008 Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018

Most influential descendants

Showing 4 of 4 · See all

K173143Phasix ST MeshC.R. Bard, Inc. · 2018 · cites it directly1descendant
K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · cites it directly1descendant
K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022 · 2 generations on0descendants
K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K971745	Bard Composite Prosthesis	Davol Inc., Sub. C. R. Bard, Inc.	1997	—
−5	K994328	Sepramesh Biosurgical Composite, Model SMBC-XXX	Genzyme Corp.	2000	—
−4	K040868	Sepramesh IP Bioresorbable Barrier - Permanent Mesh	Genzyme Corp.	2004	—
−3	K053066	Sepramesh IP Bioresorbable Coating/Permanent Mesh	Genzyme Corporation	2005	—
−2	K063739	Sepramesh, Model 5959-1214	Genzyme Corporation	2007	—
−1	K101851	Ventralight ST Mesh	Davol Inc., Sub. C. R. Bard, Inc.	2010	2
0 (this device)	K143380	Phasix ST Mesh	C.R. Bard, Inc.	2015	—
+1	K173143	Phasix ST Mesh	C.R. Bard, Inc.	2018	—
+1	K173333	GORE ENFORM Biomaterial	W. L. Gore & Associates, Inc.	2018	—
+2	K222919	GORE® ENFORM Biomaterial	W. L. Gore and Associates, Inc.	2022	—
+2	K182008	Phasix ST Mesh with Echo 2 Positioning System	C.R. Bard, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1985	1	0
2000	1	0
2001	3	0
2003	2	0
2005	1	0
2007	2	0
2011	1	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	3	0
2022	1	0

FIG. 1 — Lineage of K143380, 1997–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 OWT? 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 OWT device

#1 K261543 Phasix ST Parastomal Hernia Meshscore 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K070894	Tephaflex Surgical Mesh Summary page 4 …gulation Number: 21 CFR § 878.3300 Product Code: OWT, OOD, FTL Predicate Device Names:  TephaFLEX® Mesh , K070894/K111946/K113723 (Tepha Inc), FDA cleared on: April 13, 2007, September 26, 2011, and February 15, 2012, respectively.…	Tepha, Inc.	2007	—
*	K111946	Tephaflex Mesh Summary page 4 …Number: 21 CFR § 878.3300 Product Code: OWT, OOD, FTL Predicate Device Names:  TephaFLEX® Mesh , K070894/K111946/K113723 (Tepha Inc), FDA cleared on: April 13, 2007, September 26, 2011, and February 15, 2012, respectively.  V…	Tepha, Inc.	2011	—
*	K113723	Tephaflex Mesh Summary page 4 …21 CFR § 878.3300 Product Code: OWT, OOD, FTL Predicate Device Names:  TephaFLEX® Mesh , K070894/K111946/K113723 (Tepha Inc), FDA cleared on: April 13, 2007, September 26, 2011, and February 15, 2012, respectively.  Ventralig…	Tepha, Inc.	2012	—
*	K101851	Ventralight ST Mesh Summary page 4 …sh , K070894/K111946/K113723 (Tepha Inc), FDA cleared on: April 13, 2007, September 26, 2011, and February 15, 2012, respectively.  Ventralight ST Mesh, K101851 (Davol Inc), FDA cleared on : July 15, 2010 PREMARKET NOTIFICATION PHASIX™ ST MESH…	Davol Inc., Sub. C. R. Bard, Inc.	2010	2

Also cleared against K070894: 6 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K173143	Phasix ST Mesh	C.R. Bard, Inc.	2018	1
K173333	GORE ENFORM Biomaterial	W. L. Gore & Associates, Inc.	2018	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 18 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
1 of the 20 ancestors has a recall of any class.
Of its descendants, K173143 (C.R. Bard, Inc., 2018) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K070894.

How does its category compare?

All OWT devices

OWT Mesh, Surgical, Absorbable, Abdominal Hernia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · OWT

1in 2025

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWT

Too few OWT 510(k)s in any year since 2007 to give a median.

Recalls per year · OWT

No recall names OWT since 2007.

Adverse event reports per year · OWT

82in 2025

2007high 104 (2022) · low 0 (2007)2025

MAUDE reports naming product code OWT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	0	—	1
2015	1	—	1
2016	0	—	3
2017	1	—	7
2018	1	—	31
2019	2	—	61
2020	1	—	45
2021	0	—	58
2022	0	—	104
2023	0	—	76
2024	1	—	65
2025	1	—	82
2026	2	—	—

What is it indicated for?

The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143380 · printed Nov 5, 2026

Cite this page

510(k) Report. “K143380: Phasix ST Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143380

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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