TECHFIT Patient-Specific Cranial System

FDA 510(k) K250297 · Techfit Digital Surgery, Inc.

Substantially Equivalent

510(k) numberK250297

Submission

Device name
TECHFIT Patient-Specific Cranial System
Applicant
Techfit Digital Surgery, Inc.
Daytona Beach, FL, US
Received
January 31, 2025
Decision date
October 27, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWO – Plate, Cranioplasty, Preformed, Alterable
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5320
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code GWO

510(k)DeviceApplicantDecision
K262874CraniUS PlateGWO · Special CraniUS, LLC09/11/2026SE
K261058CraniUS PlateGWO · Traditional CraniUS, LLC07/29/2026SE
K250334Fusion Craniofacial Implant; Fusion Skull ImplantGWO · Traditional Kelyniam Global, Inc.07/25/2025SE
K231834VSP PEEK Cranial ImplantGWO · Traditional 3D Systems, Inc.04/04/2024SE
K212391MCI-Neuro Fixation SystemGWO · Traditional Mci Medical Concept Innovation, Inc.10/21/2022SE
K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional Osteonic Co., Ltd.01/27/2022SE
K203055Stryker PEEK Customized Cranial Implant KitGWO · Traditional Stryker02/09/2021SE
K190811Optimus NEURO System - Sterile KitGWO · Traditional Osteonic Co., Ltd.11/27/2019SE
K190229Stryker PEEK Customized Cranial Implant KitGWO · Traditional Stryker07/11/2019SE
K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)GWO · Traditional Kelyniam Global, Inc.05/21/2019SE

More from Kelyniam Global, Inc.

510(k)DeviceDecision
K242263TECHFIT DISRP® SystemDZJ · Traditional 12/11/2024SE
K230276TECHFIT DISRP® SystemDZJ · Traditional 06/23/2023SE
K222577TECHFIT Diagnostic ModelsLLZ · Traditional 01/06/2023SE
K220199AFFINITY Proximal Tibia SystemHRS · Traditional 03/21/2022SE

Questions and answers

When was TECHFIT Patient-Specific Cranial System cleared by the FDA?

TECHFIT Patient-Specific Cranial System (K250297) received a 510(k) decision of Substantially Equivalent on October 27, 2025, 269 days after the submission was received.

What is the product code of K250297?

The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.