510(k) · Cleared
ClearedTECHFIT Patient-Specific Cranial System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techfit Digital Surgery, Inc. · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Oct 27, 2025 as substantially equivalent to K053199 (Synthes (Usa), 2005) after a 269-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Oct 27, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K832283 (1984). 3 ancestors in all. 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 | K832283 | Medpar Surgical Implants | Porex Medical | 1984 | — |
| −1 | K053199 | Synthes Patient Specific Cranial/Craniofacial Implant | Synthes (Usa) | 2005 | — |
| 0 (this device) | K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 GWO? 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 GWO device
- #1 K261058 CraniUS Platescore 16.9 · 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 |
|---|---|---|---|
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 7…es Patient Specific Cranial/Craniofacial Implant Trade or proprietary or model name (PSCI) 510(k) number K053199 Decision date 12/14/2005 Product code GXN Manufacturer… | 2005 |
| † | K121818 | Osteofab Patient Specific Cranial Device | 2013 |
| † | K141452 | Leforte Neuro System Bone Plate and Screw | 2014 |
| † | K230276 | TECHFIT DISRP® System | 2023 |
| † | K222577 | TECHFIT Diagnostic Models | 2023 |
| † | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 |
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 41 years and passes through 3 companies; a new generation was cleared every 21.6 years on median.
- None of the 3 ancestors has a recall.
- 10 other devices also cite its predicate K053199.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The TECHFIT Patient-Specific Cranial System is intended to replace bony voids in the cranial skeleton. The devices are indicated for adults and adolescents from 18 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250297: TECHFIT Patient-Specific Cranial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250297
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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