510(k) · Cleared

Cleared

Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L

K980817510(k) TraditionalCleared Sep 25, 1998206-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 Intl. · MQV Filler, Bone Void, Calcium Compound

Cleared on Sep 25, 1998 as substantially equivalent to K960978 (Wrightmedicaltechnologyinc, 1996) and 1 other predicate after a 206-day review. Its family tree reaches back 1 generation to 1996. 312 later devices descend from it.

Decided: Sep 25, 1998
Review: 206 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K960978 (1996). 2 ancestors in all. 312 later devices descend from it, 11 citing it directly.

By dateBy generation

Root · 1 generation backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
This deviceK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
Descendant · cites it directly · 162 of its ownK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
Descendant · cites it directly · 133 of its ownK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
Descendant · 2 generations on · 123 of its ownK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
Descendant · 2 generations on · 120 of its ownK060728 Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006
Descendant · 2 generations on · 113 of its ownK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004

Showing 5 of 312 descendants. See all descendants

Descendants cleared per year

2000high 33 (2024) · low 1 (2000)2026

Most influential descendants

Showing 5 of 312 · See all

K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002 · cites it directly162descendants
K030131Ossatura BCP Bone Void FillerIsotis NV · 2003 · cites it directly133descendants
K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005 · 2 generations on123descendants
K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006 · 2 generations on120descendants
K040082Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004 · 2 generations on113descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960978	Wright Plaster of Paris Pellets (Subject to Revision)	Wrightmedicaltechnologyinc	1996	—
0 (this device)	K980817	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…	Interpore Intl.	1998	—
+1	K021336	Novabone-Resorbable Bone Graft Substitute	Novabone Products, LLC	2002	—
+1	K030131	Ossatura BCP Bone Void Filler	Isotis NV	2003	—
+2	K052494	Novabone-Bioactive Synthetic Graft	Novabone Products, LLC	2005	—
+2	K060728	Novabone Putty - Bioactive Synthetic Graft	Novabone Products, LLC	2006	—
+2	K040082	Pore-SI Bone Graft Substitute	Apatech, Ltd.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2002	2	0
2003	4	0
2004	8	0
2005	8	0
2006	9	0
2007	19	0
2008	21	0
2009	14	0
2010	10	0
2011	15	0
2012	5	0
2013	6	0
2014	17	0
2015	13	0
2016	5	0
2017	15	0
2018	11	0
2019	9	0
2020	12	0
2021	4	0
2022	11	0
2023	22	0
2024	33	0
2025	21	0
2026	16	0

FIG. 1 — Lineage of K980817, 1996–2026Source: 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? (2)

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
*	K960978	Wright Plaster of Paris Pellets (Subject to Revision) Summary page 2 …Name: Pro Osteon® 500R Resorbable Bone Void Filler PREDICATE DEVICE Wright Medical Osteoset™ Bone Void Filler (aka Wright Plaster of Paris Pellets) [reference 510(k)'s K960978 and K963562] This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements…	Wrightmedicaltechnologyinc	1996	—
*	K963562	Wright Plaster of Paris Pellets Summary page 2 …steon® 500R Resorbable Bone Void Filler PREDICATE DEVICE Wright Medical Osteoset™ Bone Void Filler (aka Wright Plaster of Paris Pellets) [reference 510(k)'s K960978 and K963562] This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §8…	Wrightmedicaltechnologyinc	1997	—

Also cleared against K960978: 1 other device →

What descends from it? (312)

See all 312

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

Number	Device	Applicant	Decided	Descendants
K021336	Novabone-Resorbable Bone Graft Substitute	Novabone Products, LLC	2002	162
K030131	Ossatura BCP Bone Void Filler	Isotis NV	2003	133
K000515	Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201…	Interpore Cross Intl.	2000	85
K012751	Healos Bone Graft Material	Orquest, Inc.	2001	84
K033679	Copsios Bone Void Filler (BVF)	Centerpulse Spine-Tech, Inc.	2004	54
K030288	Polygraft Bone Graft Substitute	Osteobiologics, Inc.	2003	33
K013960	Apatight HA-Bone Graft Substitute	Cerabio, LLC	2002	4
K062691	Comporus	Takiron Co., Ltd.	2008	0
K070897	Bonemedik, and Bonemedik-S	Meta Biomed Co., Ltd.	2007	0
K063346	Pro Osteon 500R	Ebi, L.P.	2007	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?

None of the 2 ancestors has a recall.
Of its descendants, K021336 (Novabone Products, LLC, 2002) has gone furthest, with 162 descendants of its own.
1 other device also cites its predicate K960978.

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 Void Filler is indicated only for bony voide 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 extremities, 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 void filler 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/K980817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980817

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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