510(k) · Cleared
ClearedModification to Cranioplastic, Model 43-1280
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Jul 30, 2007 as substantially equivalent to K873689 (Dentsply Intl., 1987) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 30, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P960001 (1997). 5 ancestors in all, the oldest K873689 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P960001 | Depuy 1 Bone Cement | Depuy, Inc. | 1997 | — |
| −1 | K033382 | Smartset GMV Endurance Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2004 | — |
| 0 (this device) | K071791 | Modification to Cranioplastic, Model 43-1280 | Codman & Shurtleff, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2003 | 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? (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 | Decided |
|---|---|---|---|
| * | K873689 | Cranioplastic, Acrylic Cranioplasty MaterialSummary page 1…SIFICATION: Class Ii; 21 CFR 882.5300 DEVICE PRODUCT CODE: GXP SUBSTANTIALLY EQUIVALENT Cranioplastic®(K873689) DEVICES: SmartSet GMV Endurance Gentamicin Bone Cement… | 1987 |
| * | K033382 | Smartset GMV Endurance Gentamicin Bone CementSummary page 1…Cranioplastic®(K873689) DEVICES: SmartSet GMV Endurance Gentamicin Bone Cement (K033382). DEVICE DESCRIPTION: Cranioplastic®is a self-curing, methylmethacrylate (MMA) based acrylic resin, for repairing cranial def… | 2004 |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 9 other devices also cite its predicate K873689.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Cranioplastic® is indicated for the repair of cranial defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071791: Modification to Cranioplastic, Model 43-1280.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071791
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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