Atlas FDA

KENNEDY TIBIAL COMPONENT

FDA 510(k) clearance K831513 · decided 1983-07-28

Clearance details

K-number
K831513
Device name
KENNEDY TIBIAL COMPONENT
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1983-05-12
Decision date
1983-07-28
Days to decision
77 days
Clearance type
Traditional
Product code
HSX
Device class
2
Regulation number
888.3520
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, 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
Tahoe Unicondylar Knee System with TiNbN Overcoat (K260796)Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics2026-04-02
Cambridge Partial Knee (K251771)Signature Orthopaedics Pty, Ltd.2025-12-16
Persona Partial Knee (K251834)Zimmer Biomet2025-08-15
MOTO Partial Knee System Extension (K251618)Medacta International S.A.2025-07-24
Arthrex iBalance Partial Knee System (K251453)Arthrex, Inc.2025-07-01
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
Restoris Multi-Compartmental Knee System (K220930)Mako Surgical Corp.2022-06-02

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16