510(k) · Cleared

Cleared

Pro Osteon Implant 500R Resorbable Bone Graft Substitute

K990131510(k) TraditionalCleared Mar 2, 199947-day reviewClass II21 CFR 888.3045

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

Interpore Cross Intl. · MQV Filler, Bone Void, Calcium Compound

Cleared on Mar 2, 1999 after a 47-day review. The FDA summary names no predicate by number. 224 later devices descend from it.

Decided: Mar 2, 1999
Review: 47 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 0

224 later devices descend from it, 18 citing it directly.

This deviceK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
Descendant · cites it directly · 158 of its ownK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
Descendant · cites it directly · 142 of its ownK032268 MBCPBiomatlante · 2003
Descendant · 2 generations on · 122 of its ownK043005 Modification to MBCPBiomatlante · 2005
Descendant · cites it directly · 84 of its ownK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
Descendant · 2 generations on · 67 of its ownK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005

Showing 5 of 224 descendants. See all descendants

Descendants cleared per year

2001high 15 (2009) · low 1 (2001)2026

Most influential descendants

Showing 5 of 224 · See all

K020986Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002 · cites it directly158descendants
K032268MBCPBiomatlante · 2003 · cites it directly142descendants
K043005Modification to MBCPBiomatlante · 2005 · 2 generations on122descendants
K012751Healos Bone Graft MaterialOrquest, Inc. · 2001 · cites it directly84descendants
K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005 · 2 generations on67descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute	Interpore Cross Intl.	1999	—
+1	K020986	Mastergraft Resorbable Ceramic	Medtronic Sofamor Danek, Inc.	2002	—
+1	K032268	MBCP	Biomatlante	2003	—
+2	K043005	Modification to MBCP	Biomatlante	2005	—
+1	K012751	Healos Bone Graft Material	Orquest, Inc.	2001	—
+2	K043308	Modification to: Healos Bone Graft Material	Depuy Spine, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	3	0
2003	4	0
2004	5	0
2005	11	0
2006	9	0
2007	14	0
2008	13	0
2009	15	0
2010	11	0
2011	6	0
2012	6	0
2013	1	0
2014	12	0
2015	7	0
2016	3	0
2017	7	0
2018	12	0
2019	8	0
2020	9	0
2021	9	0
2022	12	0
2023	14	0
2024	14	0
2025	11	0
2026	7	0

FIG. 1 — Lineage of K990131, 1999–2026Source: 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 MQV? 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 MQV device

#1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 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?

The FDA summary names no predicate by number.

What descends from it? (224)

See all 224

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

Number	Device	Applicant	Decided	Descendants
K020986	Mastergraft Resorbable Ceramic	Medtronic Sofamor Danek, Inc.	2002	158
K032268	MBCP	Biomatlante	2003	142
K012751	Healos Bone Graft Material	Orquest, Inc.	2001	84
K033679	Copsios Bone Void Filler (BVF)	Centerpulse Spine-Tech, Inc.	2004	54
K060432	Novabone Porous-Bone Graft Scaffold	Novabone Products, LLC	2006	19
K050025	Nanoss Bone Void Filler	Angstrom Medica, Inc.	2005	11
K014053	Conduit TCP Granules	Depuyacromed	2002	7
K093342	Biogennix RPC	Biogennix, LLC	2010	5
K013960	Apatight HA-Bone Graft Substitute	Cerabio, LLC	2002	4
K030178	Calcigen Psi Bone Graft Substitute	Biomet, Inc.	2003	3

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, K020986 (Medtronic Sofamor Danek, Inc., 2002) has gone furthest, with 158 descendants of its own.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQV

14in 2025

2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007high 214 (2016) · low 55 (2024)2026

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

Recalls per year · MQV

1in 2025

2007high 6 (2011) · low 0 (2010)2026

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

Adverse event reports per year · MQV

57in 2025

2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, 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	35	144	5	67
2008	32	102	3	71
2009	23	180	1	81
2010	17	147	0	68
2011	16	92	6	114
2012	9	107	3	149
2013	12	197	2	223
2014	20	153	0	111
2015	18	184	0	125
2016	8	214	1	106
2017	17	124	1	107
2018	23	124	2	86
2019	13	90	0	65
2020	15	132	1	126
2021	8	88	0	101
2022	9	118	0	47
2023	21	74	3	120
2024	28	55	2	68
2025	14	57	1	57
2026	5	96	4	—

What is it indicated for?

Pro Osteon 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremeities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

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/K990131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990131

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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