Medical Device Manufacturer · US , Warsaw , IN

Zimmer, Inc.

371 submissions · 350 cleared · Since 1976
371
Total
350
Cleared
0
Denied

Zimmer, Inc. — FDA 510(k) Submissions

Zimmer, Inc. has submitted 371 FDA 510(k) premarket notifications since 1976, of which 350 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Plate, Fixation, Bone, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented . Use the specialty filter in the sidebar to narrow results.

371 devices
1–25 of 371
Affixus Retrograde Femoral Nailing System
K253566 · HSB Rod, Fixation,... · Orthopedic
Mar 2026 115d
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
K253189 · MBH Prosthesis, Knee,... · Orthopedic
Mar 2026 164d
G7? Revision Acetabular System
K252623 · LPH Prosthesis, Hip,... · Orthopedic
Feb 2026 169d
Identity Revision Humeral Stems
K251098 · MBF Prosthesis, Shoulder,... · Orthopedic
Aug 2025 123d
Z1 Hip System
K251906 · LZO Prosthesis, Hip,... · Orthopedic
Jul 2025 28d
Identity Shoulder System
K250848 · MBF Prosthesis, Shoulder,... · Orthopedic
Jul 2025 104d
Persona? Revision Knee System (Persona Revision SoluTion? Femoral Components)
K243724 · JWH Prosthesis, Knee,... · Orthopedic
Mar 2025 93d
Affixus Tibial Nailing System - 4mm screws
K243907 · HSB Rod, Fixation,... · Orthopedic
Feb 2025 55d
OsseoFit Stemless Shoulder System
K241873 · PKC Prosthesis, Total... · Orthopedic
Dec 2024 167d
Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
K242543 · MBH Prosthesis, Knee,... · Orthopedic
Nov 2024 88d
Persona the Personalized Knee System
K243247 · MBH Prosthesis, Knee,... · Orthopedic
Oct 2024 18d
Affixus Tibial and Antegrade Femoral Nailing System
K241651 · HSB Rod, Fixation,... · Orthopedic
Sep 2024 111d
Identity Shoulder System
K240876 · MBF Prosthesis, Shoulder,... · Orthopedic
Jun 2024 75d
Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
K240299 · MBH Prosthesis, Knee,... · Orthopedic
Apr 2024 85d
Persona? Personalized Knee System
K230321 · JWH Prosthesis, Knee,... · Orthopedic
Mar 2023 30d
Persona Personalized Knee System
K221479 · JWH Prosthesis, Knee,... · Orthopedic
Nov 2022 178d
Zimmer Persona Personalized Knee System
K222566 · MBH Prosthesis, Knee,... · Orthopedic
Oct 2022 54d
Identity Shoulder System
K213856 · MBF Prosthesis, Shoulder,... · Orthopedic
Sep 2022 279d
G7? Vivacit-E? Freedom? Constrained Liner
K212512 · PBI Prosthesis, Hip,... · Orthopedic
Apr 2022 261d
VerSys Cemented Revision/Calcar
K210842 · JDI Prosthesis, Hip,... · Orthopedic
Dec 2021 263d
Persona Revision Knee System Femoral Metaphyseal Cones
K210829 · JWH Prosthesis, Knee,... · Orthopedic
May 2021 60d
Persona Revision Knee System
K210551 · JWH Prosthesis, Knee,... · Orthopedic
Mar 2021 21d
Zimmer Segmental System
K192798 · KRO Prosthesis, Knee,... · Orthopedic
Dec 2020 437d
ZCA All-Poly Acetabular Cups
K191449 · JDI Prosthesis, Hip,... · Orthopedic
Jul 2020 412d
Zimmer, Inc. Hip Joint Prostheses MR Labeling I
K200823 · JDI Prosthesis, Hip,... · Orthopedic
Jul 2020 101d

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