510(k) · Cleared

Cleared

Polyfuse - Neurobone

K111018510(k) TraditionalCleared Feb 14, 2012308-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

Atpac Medical, LLC · MQV Filler, Bone Void, Calcium Compound

Cleared on Feb 14, 2012 as substantially equivalent to K042340 (Kasios Biomaterials, 2004) after a 308-day review. Its family tree reaches back 1 generation to 2004.

Decided: Feb 14, 2012
Review: 308 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042340 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK042340 Kasios TCPKasios Biomaterials · 2004 · Recalled
This deviceK111018 Polyfuse - NeuroboneAtpac Medical, LLC · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042340	Kasios TCP	Kasios Biomaterials	2004	1
0 (this device)	K111018	Polyfuse - Neurobone	Atpac Medical, LLC	2012	—

FIG. 1 — Lineage of K111018, 2004–2012Source: 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

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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
*	K042340	Kasios TCP Summary page 1 …OsteoLaso Common Name: Bone Void Filler Classification Name: Resorbable Calcium Salt Bone Void Filler 3. Predicate Device: Kasios TCP (K042340) Biocompatability was tested by using ISO 10993:2003 standards. Results showed equivalence to predicate device of Kasios…	Kasios Biomaterials	2004	1

Also cleared against K042340: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 a recall.
2 other devices also cite its predicate K042340.

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. 2012, 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?

OsteoLaso Granules & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the boney structure. OsteoLaso Granules & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granules & Strips are intended to be packed into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremities posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111018: Polyfuse - Neurobone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111018

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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