Cleared Special

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

K201660 · Kyocera Medical Technologies, Inc. · Orthopedic

Jul 2020

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K201660 is an FDA 510(k) clearance for the KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System, a Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented (Class II — Special Controls, product code OQG), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on July 16, 2020, 28 days after receiving the submission on June 18, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K201660 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2020
Decision Date	July 16, 2020
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OQG — Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358
Definition	1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proximal Femur With Head Involvement, Unmanageable By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.