Atlas FDA

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM

FDA 510(k) clearance K070214 · decided 2007-03-16

Clearance details

K-number
K070214
Device name
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2007-01-23
Decision date
2007-03-16
Days to decision
52 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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Zimmer® Persona® Personalized Knee System (K251840)Zimmer, Inc.2026-05-28
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189)Zimmer, Inc.2026-03-09
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Balanced Knee System TriMax Porous Femoral Components (K253161)Ortho Development Corp.2025-12-19
Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (K252777)Maxx Orthopedics, Inc.2025-10-31
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U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (K243656)United Orthopedic Corporation2025-07-31
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Recalls involving this device

RecordFirmDate
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0199-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0200-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0201-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0202-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0203-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0204-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0205-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0206-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0207-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0208-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0209-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0210-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0211-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0212-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0213-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0214-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0215-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0216-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0217-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0218-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0219-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0220-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0221-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0222-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0223-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0224-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0225-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0226-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0227-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Si recall (Z-0228-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0229-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0230-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0231-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0232-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0233-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0234-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0235-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0236-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0237-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0238-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0239-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0240-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0241-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0242-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0243-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0244-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0245-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0246-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0247-2010)Zimmer Inc.2009-11-13
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruen recall (Z-0248-2010)Zimmer Inc.2009-11-13

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