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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 the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) 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. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K201660.

When did KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System receive FDA 510(k) clearance?

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 510(k) number K201660.

Who is the listed applicant for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06631638EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))RECRUITINGNCT02999009Trident II Tritanium Acetabular Shell Outcomes StudyACTIVE_NOT_RECRUITINGNCT05591859Restoration Anatomic Acetabular Shell Revision StudyWITHDRAWNNCT07207005Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip ArthroplastyRECRUITING

Other records listing Kyocera Medical Technologies, Inc. as applicant

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K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemK242928Tesera-k SC SystemK242045Initia T3 Acetabular Hemispherical Shell SystemK242771Tesera-k PL System and Tesera-k XL SystemK243295Initia Knee SystemK243015Skyway Anterior Cervical Plate System

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Related Devices (Code: OQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K172651FMP Extended LinersEncore Medical L.P.K171543Renovis Surgical Hip Replacement SystemRenovis Surgical TechnologiesK173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, 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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