510(k) · Cleared
ClearedOsteofab Patient Specific Cranial Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Performance Materials · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Feb 7, 2013 as substantially equivalent to K103582 (Kelyniam Global, Inc., 2011) and 4 other predicates after a 232-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Feb 7, 2013
- Review
- 232 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K904111 (1990). 14 ancestors in all, the oldest K832283 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 5 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 4 generations backK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- 3 generations backK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- 2 generations backK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- 1 generation backK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- This deviceK121818 Osteofab Patient Specific Cranial DeviceOxford Performance Materials · 2013
- Descendant · cites it directly · 0 of its ownK180064 OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −5 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −4 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| −3 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| −2 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| −1 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| 0 (this device) | K121818 | Osteofab Patient Specific Cranial Device | Oxford Performance Materials | 2013 | — |
| +1 | K180064 | OsteoFab Patient Specific Cranial Device | Oxford Performance Materials, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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 GXN? 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 GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K103582 | Kelyniam Custom Skull Implant (Csi)Summary page 1…ion: Title 21 CFR 882.5330; Preformed Non-Alterable Cranioplasty Plate; Class Il Panel: Neurology ’ Product Code: GXN Predicate Devices: Kelyniam Custom Skull Implant (K103582), Synthes Patient Specific Cranial Implant (K0S3199), Osteo-Symbionics Patient Specific Cranial Implant (K072601), MedCAD AccuSha… | 2011 |
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 5…\ i A Patient Specific | Patient Specific | Patient Specific ; Cranial Device Implant Cranial Implant Cranial Implant implant Cranial Implant (Subject Device) (K103582) (K053199) (K072601) (K110684) (K121102) Replace bony Replace bony Replace bony Corrects defects | Correct Designed Intended Use | voids in… | 2005 |
| * | K072601 | Osteosymbionics Patient Specific Cranial ImplantSummary page 1…: GXN Predicate Devices: Kelyniam Custom Skull Implant (K103582), Synthes Patient Specific Cranial Implant (K0S3199), Osteo-Symbionics Patient Specific Cranial Implant (K072601), MedCAD AccuShape PEEK Patient Specific Implant (K110684), and Osteo-Symbionics Patient Specific Cranial Implant (K121102) Desc… | 2007 |
| * | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial ImplantSummary page 1…103582), Synthes Patient Specific Cranial Implant (K0S3199), Osteo-Symbionics Patient Specific Cranial Implant (K072601), MedCAD AccuShape PEEK Patient Specific Implant (K110684), and Osteo-Symbionics Patient Specific Cranial Implant (K121102) Description of the Device An OsteoFab™ Patient Specific Crani… | 2011 |
| * | K121102 | Osteosymbionics Peek Cranial Implant Cleared while this submission was under review Summary page 1…o-Symbionics Patient Specific Cranial Implant (K072601), MedCAD AccuShape PEEK Patient Specific Implant (K110684), and Osteo-Symbionics Patient Specific Cranial Implant (K121102) Description of the Device An OsteoFab™ Patient Specific Cranial Device (OPSCD) is built individually for each patient to corre… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180064 | OsteoFab Patient Specific Cranial Device | 2018 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K180064 (Oxford Performance Materials, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103582.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, 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 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
The OsteoFab™ Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton.
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/K121818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121818: Osteofab Patient Specific Cranial Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121818
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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