Atlas FDA

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON

FDA 510(k) clearance K071107 · decided 2007-07-06

Clearance details

K-number
K071107
Device name
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2007-04-19
Decision date
2007-07-06
Days to decision
78 days
Clearance type
Traditional
Product code
MBH
Device class
2
Regulation number
888.3565
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GS recall (Z-0838-2016)Zimmer Biomet, Inc.2016-02-22

PMA approvals by this applicant

RecordFirmDate
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13