Atlas FDA

EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS

FDA 510(k) clearance K140735 · decided 2014-08-29

Clearance details

K-number
K140735
Device name
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
Applicant
Microport Orthopedics, Inc.
Decision
Substantially Equivalent
Date received
2014-03-24
Decision date
2014-08-29
Days to decision
158 days
Clearance type
Traditional
Product code
MBH
Device class
2
Regulation number
888.3565
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Arlington, TN, US
Third-party review
No
Expedited review
No

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

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Recalls involving this device

RecordFirmDate
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION recall (Z-0699-2025)MicroPort Orthopedics Inc.2024-12-18

PMA approvals by this applicant

RecordFirmDate
Ceramic Transcend® Hip Articulation System (P030027/S005)Microport Orthopedics, Inc.2018-02-16
CERAMIC TRANSCEND HIP ARTICULATION (P030027/S009)Microport Orthopedics, Inc.2016-09-01
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S008)Microport Orthopedics, Inc.2015-12-30
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S007)Microport Orthopedics, Inc.2014-01-03
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S006)Microport Orthopedics, Inc.2013-06-20
CONSERVE PLUS TOTAL RESURFACING SYSTEM (P030042/S004)Microport Orthopedics, Inc.2011-08-08
CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM (P030042/S002)Microport Orthopedics, Inc.2010-07-16
CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL (P030042/S003)Microport Orthopedics, Inc.2010-06-21