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FDA 510(k)

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

K-Number: K201660 · 2020-07-16

ApplicantKyocera Medical Technologies, Inc.
Decision Date2020-07-16
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-07-16 under approval number K201660. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2020-07-16. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K201660.

When was KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System approved by the FDA?

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System received FDA 510(k) clearance on 2020-07-16, under approval number K201660.

What company makes KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

The FDA product code for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is OQG.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by Kyocera Medical Technologies, Inc.

K200709Kyocera Bipolar Hip System K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System K212070KMTI S141 Lumbar Interbody Fusion System K203472KMTI Hip Replacement System K223105Tesera-K SC System

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Related Devices (Code: OQG)

K172651FMP Extended LinersEncore Medical L.P. K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc. K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc. K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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