510(k) · Cleared
ClearedEasymade-TI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CG Bio Co., Ltd. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Apr 9, 2026 as substantially equivalent to K210099 (Meticuly Co., Ltd., 2021) and 2 other predicates after a 265-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Apr 9, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K953806 (1996). 21 ancestors in all, the oldest K832283 (1984). No later device cites it as a predicate yet.
- Root · 7 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 6 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 5 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 4 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 3 generations backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- 2 generations backK141452 Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation · 2014
- 1 generation backK210099 Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd. · 2021
- This deviceK252251 Easymade-TICG Bio Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −6 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −5 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −4 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −3 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| −2 | K141452 | Leforte Neuro System Bone Plate and Screw | Jeil Medical Corporation | 2014 | — |
| −1 | K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | 2021 | — |
| 0 (this device) | K252251 | Easymade-TI | CG Bio Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K210099 | Meticuly Patient-Specific Titanium Mesh ImplantSummary page 6…anial surgery, and reconstructive procedures. Predicate Devices The subject device is substantially equivalent to the following predicate devices: Primary Predicate: K210099: Meticuly Patient-Specific Titanium Mesh Implant, Meticuly Co., Ltd. Additional Predicate Devices: K151692: BioArchitects Patie… | 2021 |
| * | K151692 | BioArchitects Patient Specific Cranial/Craniofacial PlateSummary page 6…ent to the following predicate devices: Primary Predicate: K210099: Meticuly Patient-Specific Titanium Mesh Implant, Meticuly Co., Ltd. Additional Predicate Devices: K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate, BioArchitects USA, LLC K220357: MedCAD AccuShape Titanium Patient-Sp… | 2015 |
| * | K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantSummary page 6…fic Titanium Mesh Implant, Meticuly Co., Ltd. Additional Predicate Devices: K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate, BioArchitects USA, LLC K220357: MedCAD AccuShape Titanium Patient-Specific Cranial Implant, MedCAD Summary of the Technological Characteristics with the Pred… | 2022 |
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 30 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K210099.
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. 2026, 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?
EASYMADE Tl is a patient-specific titanium implant that is designed individually for each patient. The device is intended for use in selective trauma of the cranial skeleton and non-load-bearing craniofacial regions (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial surgery, and reconstructive procedures.
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/K252251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252251: Easymade-TI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252251
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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