510(k) Report

510(k) · Cleared

Cleared

Norian XR Calcium Phosphate Bone Void Filler

K023862510(k) SpecialCleared Dec 19, 200229-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 (Usa) · MQV Filler, Bone Void, Calcium Compound

Cleared on Dec 19, 2002 after a 29-day review. The FDA summary names no predicate by number. 11 later devices descend from it.

Decided
Dec 19, 2002
Review
29 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2009: 2 descendants cleared2008: 1 descendant cleared2022: 2 descendants cleared2020: 1 descendant cleared2013: 1 descendant cleared2023: 2 descendants cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK023862 Norian XR Calcium Phosphate Bone Void FillerSynthes (Usa) · 2002
  2. Descendant · cites it directly · 10 of its ownK051951 Cerament Bone Void FillerBonesupport AB · 2005
  3. Descendant · 2 generations on · 6 of its ownK073316 Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
  4. Descendant · 3 generations on · 3 of its ownK201535 Cerament Bone Void FillerBonesupport AB · 2020
  5. Descendant · 4 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
  6. Descendant · 2 generations on · 2 of its ownK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12009: 22013: 12020: 12021: 12022: 22023: 2
2005high 2 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all
  • K051951Cerament Bone Void FillerBonesupport AB · 2005 · cites it directly10descendants
  • K073316Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008 · 2 generations on6descendants
  • K201535Cerament Bone Void FillerBonesupport AB · 2020 · 3 generations on3descendants
  • K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 4 generations on2descendants
  • K071004Osteocrete Bone Void FillerBone Solutions, Inc. · 2009 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023862Norian XR Calcium Phosphate Bone Void FillerSynthes (Usa)2002—
+1K051951Cerament Bone Void FillerBonesupport AB2005—
+2K073316Cerament Bone Void Filler, Model A0210Bonesupport AB2008—
+3K201535Cerament Bone Void FillerBonesupport AB2020—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.2021—
+2K071004Osteocrete Bone Void FillerBone Solutions, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
200920
201310
202010
202110
202220
202320
FIG. 1 — Lineage of K023862, 2002–2023Source: 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?

The FDA summary names no predicate by number.

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051951Cerament Bone Void FillerBonesupport AB200510

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, K051951 (Bonesupport AB, 2005) has gone furthest, with 10 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?

Norian@XR Calcium Phosphate Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian@XR Calcium Phosphate Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs over a period of years and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

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  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in MQV

The MQV category page

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https://510kreport.com/device/K023862 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023862: Norian XR Calcium Phosphate Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023862

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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