510(k) · Cleared

Cleared

Beta-TCP Granules

K120354510(k) TraditionalCleared Mar 21, 2013409-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

Skeletal Kinetics, LLC · MQV Filler, Bone Void, Calcium Compound

Cleared on Mar 21, 2013 as substantially equivalent to K040216 (Curasan AG, 2004) after a 409-day review. Its family tree reaches back 1 generation to 2004.

Decided: Mar 21, 2013
Review: 409 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K040216 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK040216 Cerasorb M OrthoCurasan AG · 2004
This deviceK120354 Beta-TCP GranulesSkeletal Kinetics, LLC · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040216	Cerasorb M Ortho	Curasan AG	2004	—
0 (this device)	K120354	Beta-TCP Granules	Skeletal Kinetics, LLC	2013	—

FIG. 1 — Lineage of K120354, 2004–2013Source: 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
*	K040216	Cerasorb M Ortho Summary page 1 …21 CER 807.92 (a) (3) The subject device is substantially equivalent in safety and effectiveness to the following legally marketed device (predicate) - Cerasorb M Ortho (K0402 16). Device Description as required by 21 CER 807.92 (a) (4) Beta TCP Granules Bone Void Filler is composed of porous, osteoconduct…	Curasan AG	2004	—

Also cleared against K040216: 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 no recall.
2 other devices also cite its predicate K040216.

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. 2013, 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?

Beta TCP Granules Bone Void Filler (BVF) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta TCP Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Beta TCP Granules BVF will resorb and be replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120354 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120354: Beta-TCP Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120354

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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