Atlas FDA

ZIMMER UNICOMPARTMENTAL KNEE SYSTEM

FDA 510(k) clearance K033363 · decided 2004-01-16

Clearance details

K-number
K033363
Device name
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2003-10-21
Decision date
2004-01-16
Days to decision
87 days
Clearance type
Traditional
Product code
HSX
Device class
2
Regulation number
888.3520
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.

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MOTO Partial Knee System Extension (K251618)Medacta International S.A.2025-07-24
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ACTIFY™ Unicondylar Knee System (K241260)Globus Medical, Inc.2024-12-06
JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (K242711)Smith & Nephew, Inc.2024-10-30
OvertureTi Knee Resurfacing SystemTM (K242746)Overture Orthopaedics2024-10-07
TRIBRID® Unicompartmental Knee System (K232114)Kyocera Medical Technologies, Inc.2024-04-04
Uni Knee Resurfacing System (K221292)Overture Resurfacing, Inc.2023-03-10
TLC Unicompartmental Knee System (K212870)Signature Orthopaedics Pty, Ltd.2022-06-16
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Recalls involving this device

RecordFirmDate
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented recall (Z-0836-2016)Zimmer Biomet, Inc.2016-02-22
Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or recall (Z-0076-2014)Zimmer, Inc.2013-10-25

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