Atlas FDA

Prime and DYNASTY® Additive Manufacturing Shells

FDA 510(k) clearance K202705 · decided 2021-08-20

Clearance details

K-number
K202705
Device name
Prime and DYNASTY® Additive Manufacturing Shells
Applicant
Microport Orthopedics, Inc.
Decision
Substantially Equivalent
Date received
2020-09-16
Decision date
2021-08-20
Days to decision
338 days
Clearance type
Traditional
Product code
OQG
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Arlington, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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