510(k) · Cleared

Cleared

Bio-Oss

K952618510(k) TraditionalCleared Aug 28, 199583-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

Geistlich-Pharma · LYC Bone Grafting Material, Synthetic

Cleared on Aug 28, 1995 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 125 later devices descend from it.

Decided: Aug 28, 1995
Review: 83 days
Class: Class II
Product code: LYC
Recalls: None
Predicates: 0

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

This deviceK952618 Bio-OssGeistlich-Pharma · 1995
Descendant · cites it directly · 124 of its ownK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
Descendant · 2 generations on · 55 of its ownK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · Recalled
Descendant · 3 generations on · 40 of its ownK052812 Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006
Descendant · 4 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
Descendant · 5 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

2004high 11 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 125 · See all

K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004 · cites it directly124descendants
K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · 2 generations on55descendants
K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006 · 3 generations on40descendants
K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 4 generations on38descendants
K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 5 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K952618	Bio-Oss	Geistlich-Pharma	1995	—
+1	K033815	Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen	Geistlich-Pharma	2004	—
+2	K043034	Osteoguide Anorganic Bone Mineral Products	Collagen Matrix, Inc.	2005	3
+3	K052812	Ossimend (TM) Bone Graft Material	Collagen Matrix, Inc.	2006	—
+4	K082166	Mastergraft Strip	Medtronic Sofamor Danek	2009	—
+5	K140375	Mastergraft Putty, Mastergraft Strip	Medtronic Sofamor Danek USA, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	2	0
2007	3	0
2008	6	0
2009	5	0
2010	10	0
2011	8	0
2012	5	0
2013	4	0
2014	5	0
2015	3	0
2017	7	0
2018	6	0
2019	5	0
2020	8	0
2021	5	0
2022	7	0
2023	9	0
2024	11	0
2025	10	0
2026	3	0

FIG. 1 — Lineage of K952618, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (125)

See all 125

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

Number	Device	Applicant	Decided	Descendants
K033815	Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen	Geistlich-Pharma	2004	124
K112572	Geistlich Combi-Kit Collegen	Geistlich Pharma AG	2011	23
K122894	Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…	Geistlich Pharma AG	2013	21
K131385	Easy-Graft	Degradable Solutions AG	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?

Of its descendants, K033815 (Geistlich-Pharma, 2004) has gone furthest, with 124 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	—

https://510kreport.com/device/K952618 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952618: Bio-Oss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952618

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026