510(k) · Cleared
Recalled · 2009Norian CRS Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · GXP Methyl Methacrylate For Cranioplasty
Cleared on Apr 13, 2006 as substantially equivalent to K973789 (Norian Corp., 1998) after a 51-day review. Its family tree reaches back 3 generations to 1987. It has been recalled once.
- Decided
- Apr 13, 2006
- Review
- 51 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K873689 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 2 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 1 generation backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- This deviceK060445 Norian CRS Bone CementSynthes (Usa) · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −2 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −1 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| 0 (this device) | K060445 | Norian CRS Bone Cement | Synthes (Usa) | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
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 GXP? 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 GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Summary page 1…use in the spine and should not be used in the presence of active or suspected infection. Predicate Device Norian CRS Bone Cement K973789 Substantial Equivalence This device is equivalent to the predicate in terms of material Determination composit… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2009 | Not classified | Z-0269-2010 | Nonconforming Material/Component | Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. The risk of Norian… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K973789.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, 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 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060445: Norian CRS Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060445
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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