510(k) · Cleared

Cleared

si-Mochi

K202639510(k) TraditionalCleared Apr 21, 2021222-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

Biostone, Ltd. · MQV Filler, Bone Void, Calcium Compound

Cleared on Apr 21, 2021 as substantially equivalent to K070132 (Orthogem Limited, 2007) and 1 other predicate after a 222-day review. Its family tree reaches back 1 generation to 2007.

Decided: Apr 21, 2021
Review: 222 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K070132 (2007). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK070132 Tripore, Models HA, BP90, BP15Orthogem Limited · 2007
This deviceK202639 si-MochiBiostone, Ltd. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K070132	Tripore, Models HA, BP90, BP15	Orthogem Limited	2007	—
0 (this device)	K202639	si-Mochi	Biostone, Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K202639, 2007–2021Source: 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

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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
*	K070132	Tripore, Models HA, BP90, BP15 Summary page 4 …the Orthopedics Device Panel as Class II Special Controls per 21 CFR 888.3045. Product code: MQV Predicate Devices TriPore® K070132, Actifuse ABX M K082575 Device Description si-Mochi contains a multi porous bi-phase Calaium Phosphate cer…	Orthogem Limited	2007	—
*	K082575	Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes Summary page 4 …Panel as Class II Special Controls per 21 CFR 888.3045. Product code: MQV Predicate Devices TriPore® K070132, Actifuse ABX M K082575 Device Description si-Mochi contains a multi porous bi-phase Calaium Phosphate ceramic granules, 1-2mm, su…	Apatech, Ltd.	2008	1

Also cleared against K070132: 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?

1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K070132.

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. 2021, 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?

si-Mochi is an implant intended to fill bony voids or gaps of the skeletal system (i.e.extremities, pelvis). These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. si-Mochi resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K202639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202639: si-Mochi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202639

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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