510(k) · Cleared

Cleared

Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250

K993610510(k) TraditionalCleared Mar 2, 2000129-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

Osteogenics Biomedical, Inc. · LYC Bone Grafting Material, Synthetic

Cleared on Mar 2, 2000 as substantially equivalent to K973594 (W. L. Gore & Associates, Inc., 1997) after a 129-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.

Decided: Mar 2, 2000
Review: 129 days
Class: Class II
Product code: LYC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K973594 (1997). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK973594 Gore Resolut XT Regenerative MaterialW. L. Gore & Associates, Inc. · 1997
This deviceK993610 Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250Osteogenics Biomedical, Inc. · 2000
Descendant · cites it directly · 5 of its ownK080308 Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd. · 2008
Descendant · 2 generations on · 2 of its ownK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
Descendant · 3 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
Descendant · 2 generations on · 1 of its ownK090083 Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009
Descendant · 3 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all

K080308Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd. · 2008 · cites it directly5descendants
K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009 · 2 generations on2descendants
K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 3 generations on1descendant
K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009 · 2 generations on1descendant
K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973594	Gore Resolut XT Regenerative Material	W. L. Gore & Associates, Inc.	1997	—
0 (this device)	K993610	Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250	Osteogenics Biomedical, Inc.	2000	—
+1	K080308	Bio-Scaffold Bioscaff Alvelac Resobable Scaffold	Bioscaffold International Pte, Ltd.	2008	—
+2	K082419	Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1	Intra-Lock International, Inc.	2009	—
+3	K101827	Osteoscaf	Texas Innovative Medical Devices (Dba) Skeletal	2011	—
+2	K090083	Cytoflex Resorb, Model C03-0010 Through C03-090	Unicare Biomedical, Inc.	2009	—
+3	K253317	Cytrans™ Elashield	GC America, Inc.	2026	—

Descendants by year cleared

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

FIG. 1 — Lineage of K993610, 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K973594	Gore Resolut XT Regenerative Material Summary page 1 …orbable Regenerative Membrane Classification Name: Implant, Endosseous For Bone Filling And/Or Augmenta- tion. PREDICATE DEVICES Gore Resolut XT Regenerative Material (K973594, W.L. Gore & Associates, Inc.) DEVICE DESCRIPTION Cytoplast™ Resorb is a bioresorbable material. Specifically, the device is de…	W. L. Gore & Associates, Inc.	1997	—

Also cleared against K973594: 3 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K080308	Bio-Scaffold Bioscaff Alvelac Resobable Scaffold	Bioscaffold International Pte, Ltd.	2008	5
K132325	Guidor Bioresorbable Matrix Barrier	Sunstar Americas, Inc.	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K080308 (Bioscaffold International Pte, Ltd., 2008) has gone furthest, with 5 descendants of its own.
3 other devices also cite its predicate K973594.

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?

As a space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures;

As a grafting material containment membrane.

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/K993610 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993610: Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993610

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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