510(k) · Cleared
ClearedSynthes Patient Specific Cranial/Craniofacial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Dec 14, 2005 as substantially equivalent to K033868 (Synthes (Usa), 2004) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1984. 34 later devices descend from it.
- Decided
- Dec 14, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832283 (1984). 2 ancestors in all. 34 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK832283 Medpar Surgical ImplantsPorex Medical · 1984
- This deviceK053199 Synthes Patient Specific Cranial/Craniofacial ImplantSynthes (Usa) · 2005
- Descendant · cites it directly · 17 of its ownK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- Descendant · cites it directly · 13 of its ownK121153 Peek Customized Craial Implant KitStryker · 2012
- Descendant · cites it directly · 13 of its ownK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- Descendant · cites it directly · 8 of its ownK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- Descendant · cites it directly · 5 of its ownK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K062570Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006 · cites it directly17descendants
- K121153Peek Customized Craial Implant KitStryker · 2012 · cites it directly13descendants
- K072707Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007 · cites it directly13descendants
- K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · cites it directly8descendants
- K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832283 | Medpar Surgical Implants | Porex Medical | 1984 | — |
| 0 (this device) | K053199 | Synthes Patient Specific Cranial/Craniofacial Implant | Synthes (Usa) | 2005 | — |
| +1 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| +1 | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| +1 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| +1 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| +1 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K033868 | Synthes (Usa) Patient Specific Cranial/Craniofacial ImplantsSummary page 1…med, alterable Predicate Devices: * Synthes Patient Specific Cranial/Craniofacial Implant, K033868 * Porex Medical: MEDPOR Porous Polyethylene Cranial Implants,… | 2004 |
| * | K832283 | Medpar Surgical ImplantsSummary page 1…K033868 * Porex Medical: MEDPOR Porous Polyethylene Cranial Implants, K832283 Device Description: The Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) rep… | 1984 |
What descends from it? (34)
See all 3411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062570 | Patient Contoured Mesh (PCM) | 2006 | 17 |
| K121153 | Peek Customized Craial Implant Kit | 2012 | 13 |
| K072707 | Patient Contoured Mesh-Peek (PCM-P) | 2007 | 13 |
| K103582 | Kelyniam Custom Skull Implant (Csi) | 2011 | 8 |
| K121755 | Custom Craniofacial Implant (Cci) | 2012 | 5 |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | 2019 | 4 |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | 2022 | 2 |
| K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate | 2015 | 2 |
| K121102 | Osteosymbionics Peek Cranial Implant | 2012 | 2 |
| K121818 | Osteofab Patient Specific Cranial Device | 2013 | 1 |
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?
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.
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?
Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053199: Synthes Patient Specific Cranial/Craniofacial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053199
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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