510(k) · Cleared
ClearedNorian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norian Corp. · GXP Methyl Methacrylate For Cranioplasty
Cleared on May 18, 1998 as substantially equivalent to K953339 (Osteogenics, Inc., 1996) and 2 other predicates after a 224-day review. Its family tree reaches back 2 generations to 1987. 49 later devices descend from it.
- Decided
- May 18, 1998
- Review
- 224 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K873689 (1987). 5 ancestors in all. 49 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 1 generation backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- This deviceK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- Descendant · cites it directly · 45 of its ownK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- Descendant · 2 generations on · 43 of its ownK021440 Bonesource HacStryker Instruments · 2002
- Descendant · 3 generations on · 41 of its ownK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- Descendant · 4 generations on · 36 of its ownK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- Descendant · 5 generations on · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999 · cites it directly45descendants
- K021440Bonesource HacStryker Instruments · 2002 · 2 generations on43descendants
- K032366Bonesource Hac Fast Setting CementStryker Instruments · 2003 · 3 generations on41descendants
- K043334Bone Source Hac Rapid Setting CementStryker Instruments · 2005 · 4 generations on36descendants
- K060061Stryker Injectable CementStryker Corp. · 2006 · 5 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −1 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| 0 (this device) | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| +1 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| +2 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| +3 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| +4 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| +5 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2026 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K953339 | Bonesource Hydroxyapatite Cement (Hac) Our OCR of the scanned summary read K953333, FDA’s number for Menstrual Tampon (Paragon Trade Brands, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Osteogenics BoneSource® Hydroxyapatite Cement”. | 1996 |
| * | K964537 | Bonesource Hydroxyapatite Cement (Hac)Summary page 1…y Affairs Summary Preparation Date: May 14, 1998 Predicate Device Norian CRST™ i3 substantially equivalent to Osteogenics BoneSource® Hydroxyapatite Cement (K953333, K964537. K970400). Device Description Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for… | 1997 |
| * | K970400 | Bone Source HydroxyapatiteSummary page 1…Summary Preparation Date: May 14, 1998 Predicate Device Norian CRST™ i3 substantially equivalent to Osteogenics BoneSource® Hydroxyapatite Cement (K953333, K964537. K970400). Device Description Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the res-… | 1997 |
What descends from it? (49)
See all 494 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K991398 (Stryker Leibinger, 1999) has gone furthest, with 45 descendants of its own.
- 3 other devices also cite its predicate K953339.
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 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 25cm².
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973789
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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