510(k) Report

510(k) · Cleared

Cleared

Chronos Tricalcium Prosphate (Chronos TCP)

K013072510(k) TraditionalCleared Nov 26, 2002439-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

Synthes · MQV Filler, Bone Void, Calcium Compound

Cleared on Nov 26, 2002 after a 439-day review. The FDA summary names its predicate without a number. 137 later devices descend from it.

Decided
Nov 26, 2002
Review
439 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

137 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2003: 3 descendants cleared2014: 5 descendants cleared2007: 4 descendants cleared2005: 2 descendants cleared2008: 4 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared2015: 5 descendants cleared2019: 3 descendants cleared2011: 5 descendants cleared2017: 4 descendants cleared2026: 13 descendants cleared2013: 4 descendants cleared2009: 2 descendants cleared2021: 4 descendants cleared2024: 27 descendants cleared2010: 4 descendants cleared2023: 14 descendants cleared2022: 6 descendants cleared2012: 1 descendant cleared2016: 2 descendants cleared2025: 19 descendants cleared2018: 3 descendants cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK013072 Chronos Tricalcium Prosphate (Chronos TCP)Synthes · 2002
  2. Descendant · cites it directly · 73 of its ownK061499 OsferionOlympus America, Inc. · 2007
  3. Descendant · 2 generations on · 71 of its ownK191974 NuVasive AttraX PuttyNu Vasive, Incorporated · 2019
  4. Descendant · 3 generations on · 66 of its ownK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
  5. Descendant · cites it directly · 55 of its ownK032409 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc. · 2003
  6. Descendant · 2 generations on · 47 of its ownK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008

Showing 5 of 137 descendants. See all descendants

Descendants cleared per year

2003: 32004: 12005: 22006: 12007: 42008: 42009: 22010: 42011: 52012: 12013: 42014: 52015: 52016: 22017: 42018: 32019: 32020: 12021: 42022: 62023: 142024: 272025: 192026: 13
2003high 27 (2024) · low 1 (2004)2026

Most influential descendants

Showing 5 of 137 · See all
  • K061499OsferionOlympus America, Inc. · 2007 · cites it directly73descendants
  • K191974NuVasive AttraX PuttyNu Vasive, Incorporated · 2019 · 2 generations on71descendants
  • K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated · 2021 · 3 generations on66descendants
  • K032409Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc. · 2003 · cites it directly55descendants
  • K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc. · 2008 · 2 generations on47descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K013072Chronos Tricalcium Prosphate (Chronos TCP)Synthes2002—
+1K061499OsferionOlympus America, Inc.2007—
+2K191974NuVasive AttraX PuttyNu Vasive, Incorporated2019—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar…Nu Vasive, Incorporated2021—
+1K032409Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc.2003—
+2K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &…Orthovita, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
200410
200520
200610
200740
200840
200920
201040
201150
201210
201340
201450
201550
201620
201740
201830
201930
202010
202140
202260
2023140
2024270
2025190
2026130
FIG. 1 — Lineage of K013072, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Pro Osteon 500R Resorbable Bone Void Filler
Named without a submission number
—
*—Vitoss Scaffold Synthetic Bone Void filler
Named without a submission number
—

What descends from it? (137)

See all 137

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

NumberDeviceApplicantDecidedDescendants
K061499OsferionOlympus America, Inc.200773
K032409Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc.200355
K071046Synthes Chronos CompositeSynthes (Usa)20079
K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.20033
K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141
K051775Osteomimetic Synthetic Bone MatrixBiomimetic Pharmaceuticals, Inc.20050

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?

  • Of its descendants, K061499 (Olympus America, Inc., 2007) has gone furthest, with 73 descendants of its own.

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

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
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

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

Synthes ChronOS is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. ChronOS is indicated for use in the treatment of bony defects created surgically or through traumatic injury.

ChronOS Tricalcium Phosphate is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

More from Synthes

11 FDA decisions under this applicant name. See the company

  • K123723Synthes Matrixneuro Cranial Plating SystemSynthes · 2013
  • K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 20132 recalls
  • K113071Synthecel Dura Replacement DevicesSynthes · 20125 recalls
  • K110604VBB SystemSynthes · 20111 recall
  • K093772Synthes Sternal Fixation SystemSynthes · 2010

Recent decisions in MQV

The MQV category page

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  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K253524Adaptos®Fuse Bone GraftBiomendex OY · 2026

https://510kreport.com/device/K013072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013072: Chronos Tricalcium Prosphate (Chronos TCP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013072

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026