510(k) · Cleared

Cleared

Phasix Plug and Patch

K120728510(k) TraditionalCleared Oct 22, 2012227-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 Oct 22, 2012 as substantially equivalent to K111946 (Tepha, Inc., 2011) and 2 other predicates after a 227-day review. Its family tree reaches back 4 generations to 2001.

Decided: Oct 22, 2012
Review: 227 days
Class: Class II
Product code: OWT
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K002699 (2001). 12 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
3 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
2 generations backK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
1 generation backK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
This deviceK120728 Phasix Plug and PatchC.R. Bard, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K002699	Parietex Composite (Pco) Mesh	Medical Device Consultants, Inc.	2001	—
−3	K031955	Macropore Surgi-Wrap Mast Bioresorbable Sheet	Macropore Biosurgery, Inc.	2003	—
−2	K050332	Surgi-Wrap Mast Bioresorbable Sheet	Mast Biosurgery USA, Inc.	2005	—
−1	K070894	Tephaflex Surgical Mesh	Tepha, Inc.	2007	—
0 (this device)	K120728	Phasix Plug and Patch	C.R. Bard, Inc.	2012	—

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
2009	1	0
2011	1	0

FIG. 1 — Lineage of K120728, 2001–2012Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K111946	Tephaflex Mesh	Tepha, Inc.	2011	—
*	K070894	Tephaflex Surgical Mesh Summary page 1 …Class 11, § 878.3300, Product Code OWT (primary), OOD) Predicate Device Names: " TephaFLEX® Mesh, Ki 11946 and K070894 (Tepha Inc.), FDA cleared on September 26, 2011 and April 13, 2007 * Bard® PerFix Tm Light Plug, K092032 (Davol Inc.), FD…	Tepha, Inc.	2007	—
*	K092032	Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 Summary page 1 …dicate Device Names: " TephaFLEX® Mesh, Ki 11946 and K070894 (Tepha Inc.), FDA cleared on September 26, 2011 and April 13, 2007 * Bard® PerFix Tm Light Plug, K092032 (Davol Inc.), FDA cleared on December 8, 2009 PREMARKET NOTIFICATION FOR PHASIXTM PLUG AND PATCH…	Davol Inc., Sub. C. R. Bard, Inc.	2009	1

Also cleared against K111946: 3 other devices →

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 11 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
1 of the 12 ancestors has a recall of any class.
3 other devices also cite its predicate K111946.

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. 2012, 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 PhasixTM Plug and Patch is indicated for reinforcement of soft tissue, where weakness exists, in procedures involying soft tissue repair, such as groin hernia defects.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120728 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120728: Phasix Plug and Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120728

Report an extraction error

Are you the manufacturer?

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