Atlas FDA

ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM

FDA 510(k) clearance K123459 · decided 2013-02-22

Clearance details

K-number
K123459
Device name
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2012-11-09
Decision date
2013-02-22
Days to decision
105 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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Similar devices under this product code

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

RecordFirmDate
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
GMK 3D Metal Tibial Tray Extension (K253328)Medacta International S.A.2026-02-26
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (K253637)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026-02-18
Active-V Total Knee System; World Total Knee System (K253239)Signature Orthopaedics Pty, Ltd.2025-12-23
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
Triathlon® Total Knee System - Triathlon® Gold Femoral Components (K252044)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-10-24
U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (K243656)United Orthopedic Corporation2025-07-31
Physica System (Physica CR Porous Femoral components) (K250980)Lima Corporate S.P.A.2025-05-22
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768)Restor3D, Inc.2025-03-27
Freedom® Total Knee System - Porous Tibial Base Plate (K241597)Maxx Orthopedics, Inc.2025-02-13

Recalls involving this device

RecordFirmDate
Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Numbe recall (Z-1052-2015)Zimmer, Inc.2015-02-04
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTT recall (Z-2575-2014)Zimmer, Inc.2014-09-04
PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Sur recall (Z-2576-2014)Zimmer, Inc.2014-09-04
PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the foll recall (Z-2577-2014)Zimmer, Inc.2014-09-04
PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the fo recall (Z-2578-2014)Zimmer, Inc.2014-09-04
PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Siz recall (Z-2579-2014)Zimmer, Inc.2014-09-04
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3- recall (Z-2580-2014)Zimmer, Inc.2014-09-04
Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nons recall (Z-2298-2014)Zimmer, Inc.2014-08-21
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nons recall (Z-2300-2014)Zimmer, Inc.2014-08-21
Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Non recall (Z-2301-2014)Zimmer, Inc.2014-08-21

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