510(k) · Cleared

Cleared

Facial Reconstructive Mesh (FRM)

K063154510(k) TraditionalCleared Jul 10, 2007267-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

Evera Medical, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Jul 10, 2007 as substantially equivalent to K851086 (ETHICON, Inc., 1985) and 3 other predicates after a 267-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jul 10, 2007
Review: 267 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K973379 (1997). 10 ancestors in all, the oldest K851086 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK973379 Sterile Suprafoil Smooth Nylon Foil SheetsS. Jackson, Inc. · 1997
1 generation backK013625 PermacolTissue Science Laboratories, Plc · 2002
This deviceK063154 Facial Reconstructive Mesh (FRM)Evera Medical, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K973379	Sterile Suprafoil Smooth Nylon Foil Sheets	S. Jackson, Inc.	1997	—
−1	K013625	Permacol	Tissue Science Laboratories, Plc	2002	—
0 (this device)	K063154	Facial Reconstructive Mesh (FRM)	Evera Medical, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1995	1	0
1997	2	0
2000	3	0
2001	1	0

FIG. 1 — Lineage of K063154, 1997–2007Source: 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 FTL? 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 FTL device

#1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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
*	K851086	Vicryl (Polyglactin 910/Mersilene Compoisite Mesh Summary page 1 …lass: Class II Predicate Device(s): Trade Name: Mersilene Polyester Fiber Mesh Manufacturer: Ethicon, Inc. K Number: K851086 Product Code: FTM Trade Name: PermacolITM Crosslinked Porcine Dermal Collagen Surgical…	ETHICON, Inc.	1985	—
*	K013625	Permacol Summary page 1 …olITM Crosslinked Porcine Dermal Collagen Surgical Mesh Manufacturer: Tissue Sciences Laboratories PLC K Number: K013625 Product Code: FTM Trade Name: Gore-Tex SAM Facial Implant with Introducer Manufacturer.…	Tissue Science Laboratories, Plc	2002	—
*	K952898	Gore-Tex Sam Facial Implant with Introducer Summary page 1 …e: FTM Trade Name: Gore-Tex SAM Facial Implant with Introducer Manufacturer. W.L. Gore and Associates, Inc. K Number: K952898 Product Code: FTL /…	W. L. Gore & Associates, Inc.	1995	—
*	K971745	Bard Composite Prosthesis Summary page 2 …Replacement for Original Page 7 Trade Name: Bard Composite Prosthesis Manufacturer: Davol, Inc. K Number: K971745 Product Code: FTL Device Description: The FRM is a non-absorbable, inert, sterile, porous,…	Davol Inc., Sub. C. R. Bard, Inc.	1997	—

Also cleared against K851086: 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 10 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
None of the 10 ancestors has a recall.
3 other devices also cite its predicate K851086.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	0	—

What is it indicated for?

The Facial Reconstructive Mesh is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063154 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063154: Facial Reconstructive Mesh (FRM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063154

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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