Atlas FDA

ZIMMER PERSONA KNEE SYSTEM

FDA 510(k) clearance K113369 · decided 2012-03-27

Clearance details

K-number
K113369
Device name
ZIMMER PERSONA KNEE SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2011-11-15
Decision date
2012-03-27
Days to decision
133 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
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
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

RecordFirmDate
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Heig recall (Z-1340-2016)Zimmer Manufacturing B.V.2016-04-06
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Heig recall (Z-1341-2016)Zimmer Manufacturing B.V.2016-04-06
Product 59 consists of all product under product code: JWH and same usage: Item no: 425400 recall (Z-1157-2016)Zimmer Manufacturing B.V.2016-03-12
Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior Refe recall (Z-1360-2015)Zimmer, Inc.2015-04-01
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical i recall (Z-1042-2015)Zimmer, Inc.2015-02-03
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inse recall (Z-0853-2015)Zimmer, Inc.2014-12-23
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patien recall (Z-0198-2015)Zimmer, Inc.2014-11-08
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for us recall (Z-0123-2015)Zimmer, Inc.2014-10-23
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 PS Tibial Articular Surface Provisional Top Nons recall (Z-2296-2014)Zimmer, Inc.2014-08-21
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nons recall (Z-2297-2014)Zimmer, Inc.2014-08-21
Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nons recall (Z-2299-2014)Zimmer, Inc.2014-08-21
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium S recall (Z-0539-2013)Zimmer, Inc.2012-12-18
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium S recall (Z-0540-2013)Zimmer, Inc.2012-12-18
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium S recall (Z-0541-2013)Zimmer, Inc.2012-12-18
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium S recall (Z-0542-2013)Zimmer, Inc.2012-12-18
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium S recall (Z-0543-2013)Zimmer, Inc.2012-12-18
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium S recall (Z-0544-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile recall (Z-0545-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Non recall (Z-0546-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, Thi recall (Z-0547-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This recall (Z-0548-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This recall (Z-0549-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C L recall (Z-0550-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D L recall (Z-0551-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E L recall (Z-0552-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F L recall (Z-0553-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G L recall (Z-0554-2013)Zimmer, Inc.2012-12-18
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H L recall (Z-0555-2013)Zimmer, Inc.2012-12-18
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibi recall (Z-2493-2012)Zimmer, Inc.2012-09-28

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