Atlas FDA

EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

FDA 510(k) clearance K162026 · decided 2017-03-01

Clearance details

K-number
K162026
Device name
EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
Applicant
Microport Orthopedics, Inc.
Decision
Substantially Equivalent
Date received
2016-07-22
Decision date
2017-03-01
Days to decision
222 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Arlington, TN, 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
Freedom Total Knee System (E-Poly Tibial Liners) (K261563)Maxx Orthopedics, Inc.2026-08-07
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (K262251)Globus Medical, Inc.2026-07-31
Klassic Infection Spacer System (K261734)Total Joint Orthopedics, Inc.2026-07-23
ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458)DePuy Ireland UC2026-06-25
NovoKnee (SteriKnee) (K261032)NovoSource2026-04-27
Materialise TKA Guide System (K253793)Materialise NV2026-01-06
EMPOWR Knee (K252974)Encore Medical L.P.2025-12-19
ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197)Depuy Ireland UC2025-11-19
Freedom Infinia™ Total Knee System (K253314)Maxx Orthopedics, Inc.2025-10-29
Freedom® Total Knee System – Titan PCK Components (K253144)Maxx Orthopedics, Inc.2025-10-22
Stem Extension Line (U2 Total Knee System—PSA Type) (K252725)United Orthopedic Corporation2025-09-25
Materialise TKA Guide System (K251554)Materialise NV2025-07-14

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