510(k) · Cleared

Cleared

Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1

K082419510(k) AbbreviatedCleared May 27, 2009278-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

Intra-Lock International, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on May 27, 2009 as substantially equivalent to K071237 (Kensey Nash Corp., 2007) and 7 other predicates after a 278-day review. Its family tree reaches back 8 generations to 1987. 2 later devices descend from it.

Decided: May 27, 2009
Review: 278 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 8

Its longest line of descent runs back 8 generations to K873689 (1987). 52 ancestors in all, the oldest K860983 (1986). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
7 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
6 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
5 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
4 generations backK021440 Bonesource HacStryker Instruments · 2002
3 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
2 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
1 generation backK060061 Stryker Injectable CementStryker Corp. · 2006
This deviceK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
Descendant · cites it directly · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
Descendant · 2 generations on · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022

Most influential descendants

Showing 2 of 2 · See all

K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · cites it directly1descendant
K213260CMFlexTMDimension Inx Corp. · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K873689	Cranioplastic, Acrylic Cranioplasty Material	Dentsply Intl.	1987	—
−7	K953339	Bonesource Hydroxyapatite Cement (Hac)	Osteogenics, Inc.	1996	—
−6	K973789	Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair…	Norian Corp.	1998	—
−5	K991398	Bonesource Hydroxyapatite Cement (Hac) Expanded Kit	Stryker Leibinger	1999	—
−4	K021440	Bonesource Hac	Stryker Instruments	2002	—
−3	K032366	Bonesource Hac Fast Setting Cement	Stryker Instruments	2003	—
−2	K043334	Bone Source Hac Rapid Setting Cement	Stryker Instruments	2005	—
−1	K060061	Stryker Injectable Cement	Stryker Corp.	2006	—
0 (this device)	K082419	Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1	Intra-Lock International, Inc.	2009	—
+1	K101827	Osteoscaf	Texas Innovative Medical Devices (Dba) Skeletal	2011	—
+2	K213260	CMFlexTM	Dimension Inx Corp.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	2	0
1992	1	0
1996	2	0
1997	4	0
1998	3	0
1999	2	0
2000	3	0
2001	6	0
2002	2	0
2003	2	0
2004	10	0
2005	4	0
2007	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2022	1	0

FIG. 1 — Lineage of K082419, 1987–2022Source: 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? (8)

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
*	K071237	Copios Bone Void Filler Sponge and Paste Summary page 1 …void filler device 888.3045 Device Classification: Class Il Predicate Devices: : i AT e ‘ Product , ‘Granular Manufacturer Code - K#: Copios BVF Kensy Nash/Zimmer MQV K071237 Eovia Orthotec MQV K040514 OsSatura Isotis LYC K042706 Bio-Scaffold Bioscaff Alvelac International Pte Ltd. LYC K080308 IR . i…	Kensey Nash Corp.	2007	—
*	K040514	Eovia Calcium Phosphate Ceramic Summary page 1 …Device Classification: Class Il Predicate Devices: : i AT e ‘ Product , ‘Granular Manufacturer Code - K#: Copios BVF Kensy Nash/Zimmer MQV K071237 Eovia Orthotec MQV K040514 OsSatura Isotis LYC K042706 Bio-Scaffold Bioscaff Alvelac International Pte Ltd. LYC K080308 IR . i _ Product Putty Manufacture…	Ortho Tec, LLC	2004	—
*	K042706	Ossatura Dental Summary page 1 …ss Il Predicate Devices: : i AT e ‘ Product , ‘Granular Manufacturer Code - K#: Copios BVF Kensy Nash/Zimmer MQV K071237 Eovia Orthotec MQV K040514 OsSatura Isotis LYC K042706 Bio-Scaffold Bioscaff Alvelac International Pte Ltd. LYC K080308 IR . i _ Product Putty Manufacturer ‘Code- K# Stryker TCP Stry…	Isotis Orthobiologics, Inc.	2004	—
*	K080308	Bio-Scaffold Bioscaff Alvelac Resobable Scaffold Summary page 1 …urer Code - K#: Copios BVF Kensy Nash/Zimmer MQV K071237 Eovia Orthotec MQV K040514 OsSatura Isotis LYC K042706 Bio-Scaffold Bioscaff Alvelac International Pte Ltd. LYC K080308 IR . i _ Product Putty Manufacturer ‘Code- K# Stryker TCP Stryker MQV K060061 Optimum DBM LifeNet MQv K053098 Actifuse ABX E-Z f…	Bioscaffold International Pte, Ltd.	2008	—
*	K060061	Stryker Injectable Cement Summary page 1 …0514 OsSatura Isotis LYC K042706 Bio-Scaffold Bioscaff Alvelac International Pte Ltd. LYC K080308 IR . i _ Product Putty Manufacturer ‘Code- K# Stryker TCP Stryker MQV K060061 Optimum DBM LifeNet MQv K053098 Actifuse ABX E-Z fil Apatec MQV K071206 Dynagraft Isotis MQv K040419 o : Product L Putty- - -Ma…	Stryker Corp.	2006	—
*	K053098	Optium DBM Gel and Putty Summary page 1 …Bio-Scaffold Bioscaff Alvelac International Pte Ltd. LYC K080308 IR . i _ Product Putty Manufacturer ‘Code- K# Stryker TCP Stryker MQV K060061 Optimum DBM LifeNet MQv K053098 Actifuse ABX E-Z fil Apatec MQV K071206 Dynagraft Isotis MQv K040419 o : Product L Putty- - -Manufacturer Code K# . i Optimum D…	Lifenet	2005	—
*	K071206	Actifuse Abx E-Z-Fil Putty Bone Graft Substitute Summary page 1 …ional Pte Ltd. LYC K080308 IR . i _ Product Putty Manufacturer ‘Code- K# Stryker TCP Stryker MQV K060061 Optimum DBM LifeNet MQv K053098 Actifuse ABX E-Z fil Apatec MQV K071206 Dynagraft Isotis MQv K040419 o : Product L Putty- - -Manufacturer Code K# . i Optimum DBM LifeNet MQv K053098 DynaGraft Isotis…	Apatech, Ltd.	2007	1
*	K040419	Dynagraft II Summary page 1 …R . i _ Product Putty Manufacturer ‘Code- K# Stryker TCP Stryker MQV K060061 Optimum DBM LifeNet MQv K053098 Actifuse ABX E-Z fil Apatec MQV K071206 Dynagraft Isotis MQv K040419 o : Product L Putty- - -Manufacturer Code K# . i Optimum DBM LifeNet MQv K053098 DynaGraft Isotis MQv K040419 M…	Isotis Orthobiologics, Inc.	2005	—

Also cleared against K071237: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101827	Osteoscaf	Texas Innovative Medical Devices (Dba) Skeletal	2011	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?

The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
6 of the 52 ancestors have a recall of any class.
Of its descendants, K101827 (Texas Innovative Medical Devices (Dba) Skeletal, 2011) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K071237.

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. 2009, this device’s year, is highlighted.

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?

ReOss Powder, Putty and Gel are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

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/K082419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082419: Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082419

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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