510(k) · Cleared

Cleared

Gore Resolut XT Regenerative Material

K973594510(k) TraditionalCleared Dec 17, 199786-day reviewClass II21 CFR 872.3930

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

W. L. Gore & Associates, Inc. · LYC Bone Grafting Material, Synthetic

Cleared on Dec 17, 1997 after an 86-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided: Dec 17, 1997
Review: 86 days
Class: Class II
Product code: LYC
Recalls: None
Predicates: 0

11 later devices descend from it, 4 citing it directly.

This deviceK973594 Gore Resolut XT Regenerative MaterialW. L. Gore & Associates, Inc. · 1997
Descendant · cites it directly · 8 of its ownK033074 Inion GTR Biodegradable Membrane SystemInion, Ltd. · 2004 · Recalled
Descendant · cites it directly · 7 of its ownK993610 Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250Osteogenics Biomedical, Inc. · 2000
Descendant · 2 generations on · 5 of its ownK080308 Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd. · 2008
Descendant · 3 generations on · 2 of its ownK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
Descendant · cites it directly · 2 of its ownK990363 Biomesh Biodegradable GTR BarrierSamyang Corp. · 1999

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1999high 2 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 11 · See all

K033074Inion GTR Biodegradable Membrane SystemInion, Ltd. · 2004 · cites it directly8descendants
K993610Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250Osteogenics Biomedical, Inc. · 2000 · cites it directly7descendants
K080308Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd. · 2008 · 2 generations on5descendants
K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009 · 3 generations on2descendants
K990363Biomesh Biodegradable GTR BarrierSamyang Corp. · 1999 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973594	Gore Resolut XT Regenerative Material	W. L. Gore & Associates, Inc.	1997	—
+1	K033074	Inion GTR Biodegradable Membrane System	Inion, Ltd.	2004	1
+1	K993610	Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250	Osteogenics Biomedical, Inc.	2000	—
+2	K080308	Bio-Scaffold Bioscaff Alvelac Resobable Scaffold	Bioscaffold International Pte, Ltd.	2008	—
+3	K082419	Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1	Intra-Lock International, Inc.	2009	—
+1	K990363	Biomesh Biodegradable GTR Barrier	Samyang Corp.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2004	1	0
2008	1	0
2009	2	0
2011	1	0
2013	2	0
2022	1	0
2026	1	0

FIG. 1 — Lineage of K973594, 1997–2026Source: 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 LYC? 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 LYC device

#1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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? (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	Applicant	Decided	Recalls
*	—	GORE RESOLUT Regenerative Material Named without a submission number			—

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K033074	Inion GTR Biodegradable Membrane System	Inion, Ltd.	2004	8
K993610	Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250	Osteogenics Biomedical, Inc.	2000	7
K990363	Biomesh Biodegradable GTR Barrier	Samyang Corp.	1999	2
K090083	Cytoflex Resorb, Model C03-0010 Through C03-090	Unicare Biomedical, Inc.	2009	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?

Of its descendants, K033074 (Inion, Ltd., 2004) has gone furthest, with 8 descendants of its own.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007high 267 (2025) · low 73 (2008)2026

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

Recalls per year · LYC

1in 2018

2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · LYC

2in 2025

2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, 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	13	80	0	23
2008	8	73	0	25
2009	14	100	1	25
2010	13	164	2	28
2011	9	224	0	21
2012	5	120	2	10
2013	2	—	0	12
2014	1	—	0	9
2015	0	—	0	14
2016	2	—	2	140
2017	0	—	0	19
2018	0	—	1	14
2019	0	—	0	15
2020	3	156	0	5
2021	0	—	0	12
2022	2	—	0	6
2023	0	—	0	9
2024	0	—	0	6
2025	3	267	0	2
2026	3	266	0	—

What is it indicated for?

GORE RESOLUT XT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, GORE RESOLUT XT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973594 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973594: Gore Resolut XT Regenerative Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973594

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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