510(k) · Cleared
ClearedOsteosymbionics Patient-Specific Cranial Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteosymbionics, LLC · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on May 20, 2014 as substantially equivalent to K072601 (Osteosymbionics, LLC, 2007) after a 232-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- May 20, 2014
- Review
- 232 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904111 (1990). 6 ancestors in all, the oldest K873689 (1987). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 2 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 1 generation backK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- This deviceK133082 Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC · 2014
- Descendant · cites it directly · 4 of its ownK170410 Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC · 2018
- Descendant · 2 generations on · 3 of its ownK191210 Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC · 2020
- Descendant · 3 generations on · 2 of its ownK203349 Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC · 2020
- Descendant · 4 generations on · 1 of its ownK231920 Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC · 2023
- Descendant · 5 generations on · 0 of its ownK260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot…Longeviti Neuro Solutions · 2026
Most influential descendants
Showing 5 of 5 · See all- K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC · 2018 · cites it directly4descendants
- K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC · 2020 · 2 generations on3descendants
- K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC · 2020 · 3 generations on2descendants
- K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC · 2023 · 4 generations on1descendant
- K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…Longeviti Neuro Solutions · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −2 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −1 | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| 0 (this device) | K133082 | Osteosymbionics Patient-Specific Cranial Plate | Osteosymbionics, LLC | 2014 | — |
| +1 | K170410 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | 2018 | — |
| +2 | K191210 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020 | — |
| +3 | K203349 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020 | — |
| +4 | K231920 | Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions, LLC | 2023 | — |
| +5 | K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot… | Longeviti Neuro Solutions | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K072601 | Osteosymbionics Patient Specific Cranial ImplantSummary page 1…afety and effectiveness to the following legally marketed device: OsteoSymbionics Patient-Specific Cranial Implants (K072601) These devices are identical except for the modification that they will be pa… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170410 | Longeviti PMMA Static Cranial Implant | 2018 | 4 |
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 24 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K170410 (Longeviti Neuro Solutions, LLC, 2018) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K072601.
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. 2014, 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 OsteoSynibionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133082: Osteosymbionics Patient-Specific Cranial Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133082
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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