510(k) · Cleared

Cleared

Callos

K030554510(k) TraditionalCleared May 20, 200388-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 May 20, 2003 as substantially equivalent to K011897 (Synthes (Usa), 2001) after an 88-day review. Its family tree reaches back 1 generation to 2001. 11 later devices descend from it.

Decided: May 20, 2003
Review: 88 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011897 (2001). 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK011897 Norian SRS Bone Void FillerSynthes (Usa) · 2001
This deviceK030554 CallosSkeletal Kinetics, LLC · 2003
Descendant · cites it directly · 9 of its ownK051123 Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 2005 · Recalled
Descendant · cites it directly · 3 of its ownK042072 Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · Recalled
Descendant · 2 generations on · 2 of its ownK051784 Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 2005 · Recalled
Descendant · 3 generations on · 1 of its ownK162864 OsteoVation ImpactSkeletal Kinetics, LLC · 2017 · Recalled
Descendant · 2 generations on · 1 of its ownK132211 Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC · 2014

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all

K051123Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 2005 · cites it directly9descendants
K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · cites it directly3descendants
K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 2005 · 2 generations on2descendants
K162864OsteoVation ImpactSkeletal Kinetics, LLC · 2017 · 3 generations on1descendant
K132211Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC · 2014 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011897	Norian SRS Bone Void Filler	Synthes (Usa)	2001	—
0 (this device)	K030554	Callos	Skeletal Kinetics, LLC	2003	—
+1	K051123	Callos Impact and Inject Bone Void Filler	Skeletal Kinetics, LLC	2005	17
+1	K042072	Callos CMF Bone Void Filler	Skeletal Kinetics, LLC	2004	10
+2	K051784	Osteovation CMF Bone Void Filler	Skeletal Kinetics, LLC	2005	13
+3	K162864	OsteoVation Impact	Skeletal Kinetics, LLC	2017	7
+2	K132211	Skaffold NMX Bone Void Filler	Skeletal Kinetics, LLC	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2010	1	0
2012	1	0
2014	1	0
2017	1	0
2019	1	0
2020	1	0
2021	2	0

FIG. 1 — Lineage of K030554, 2001–2021Source: 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? (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
*	K011897	Norian SRS Bone Void Filler	Synthes (Usa)	2001	—

Also cleared against K011897: 10 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K051123	Callos Impact and Inject Bone Void Filler	Skeletal Kinetics, LLC	2005	9
K042072	Callos CMF Bone Void Filler	Skeletal Kinetics, LLC	2004	3
K100986	Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation	Skeletal Kinetics, LLC	2010	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?

Its one ancestor has no recall.
Of its descendants, K051123 (Skeletal Kinetics, LLC, 2005) has gone furthest, with 9 descendants of its own.
10 other devices also cite its predicate K011897.

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?

Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The 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/K030554 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030554: Callos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030554

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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