Medical Device Manufacturer · DE , Buxtehude

Implantcast GmbH

18 submissions · 18 cleared · Since 2017
18
Total
18
Cleared
0
Denied

Implantcast GmbH — FDA 510(k) Submissions

Implantcast GmbH has submitted 18 FDA 510(k) premarket notifications since 2017, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented, Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
implaFit? short stems
K252401 · LZO Prosthesis, Hip,... · Orthopedic
Mar 2026 224d
AGILON? XO Shoulder Replacement System
K241944 · KWT Prosthesis, Shoulder,... · Orthopedic
Mar 2025 251d
MUTARS? femoral stem cemented 160 mm and 200 mm
K240391 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2024 259d
ACS? LD FB Knee System
K234044 · JWH Prosthesis, Knee,... · Orthopedic
Sep 2024 260d
EcoFit? short stem cementless cpTi
K240834 · LZO Prosthesis, Hip,... · Orthopedic
Jun 2024 69d
AGILON? XO Shoulder Replacement System
K231657 · KWT Prosthesis, Shoulder,... · Orthopedic
Feb 2024 254d
Actinia? hip stems
K232371 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2023 72d
BethaLoc? stem cementless HA
K223103 · LZO Prosthesis, Hip,... · Orthopedic
Jun 2023 263d
AGILON XO Shoulder System
K222482 · KWT Prosthesis, Shoulder,... · Orthopedic
Sep 2022 42d
implaFit? hip stems
K210678 · LZO Prosthesis, Hip,... · Orthopedic
Aug 2022 530d
EcoFit? Hip System
K203420 · LZO Prosthesis, Hip,... · Orthopedic
Feb 2021 76d
ACS LD Uni FB Knee System
K203341 · HSX Prosthesis, Knee,... · Orthopedic
Jan 2021 57d
AGILON? XO Shoulder Replacement System
K191433 · HSD Prosthesis, Shoulder,... · Orthopedic
Nov 2020 533d
MUTARS Cemented Femoral Stems
K200045 · MEH Prosthesis, Hip,... · Orthopedic
Oct 2020 282d
Implantcast ic-Bipolar Head System
K191569 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Aug 2019 76d
MUTARS Proximal Femur Replacement System
K181778 · MEH Prosthesis, Hip,... · Orthopedic
Mar 2019 265d
EcoFit Vit E Acetabular System
K180263 · LZO Prosthesis, Hip,... · Orthopedic
Jul 2018 171d
Ecofit? Hip System
K163577 · LZO Prosthesis, Hip,... · Orthopedic
Sep 2017 279d
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