Atlas FDA

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

FDA 510(k) clearance K201660 · decided 2020-07-16

Clearance details

K-number
K201660
Device name
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Applicant
Kyocera Medical Technologies, Inc.
Decision
Substantially Equivalent
Date received
2020-06-18
Decision date
2020-07-16
Days to decision
28 days
Clearance type
Special
Product code
OQG
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Redlands, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Prime and DYNASTY® Additive Manufacturing Shells (K202705)Microport Orthopedics, Inc.2021-08-20
KMTI Hip Replacement System (K203472)Kyocera Medical Technologies, Inc.2021-04-02
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (K200328)Kyocera Medical Technologies, Inc.2020-03-11
FMP Extended Liners (K172651)Encore Medical L.P.2017-12-13
Renovis Surgical Hip Replacement System (K171543)Renovis Surgical Technologies2017-11-16
Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly (K173104)Total Joint Orthopedics, Inc.2017-10-27
Renovis Surgical Hip Replacement System (K143647)Renovis Surgical Technologies, Inc.2015-05-11
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED (K140130)Encore Medical L.P.2014-11-06
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY (K141972)Total Joint Orthopedics, Inc.2014-10-09
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG (K140701)Novosource, Inc.2014-06-27
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT (K130652)Consensus Orthopedics, Inc.2013-12-17
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (K122783)Aesculap Implant System, Inc.2013-10-30

Recalls involving this device

No recalls on record reference this clearance.