Medical Device Manufacturer · US , Winona Lake , IN

Lima Corporate S.P.A.

64 submissions · 64 cleared · Since 2011
64
Total
64
Cleared
0
Denied

Lima Corporate S.P.A. — FDA 510(k) Submissions

Lima Corporate S.P.A. has submitted 64 FDA 510(k) premarket notifications since 2011, of which 64 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Shoulder Prosthesis, Reverse Configuration, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented, Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented . Use the specialty filter in the sidebar to narrow results.

64 devices
1–25 of 64
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
K252352 · PHX Shoulder Prosthesis,... · Orthopedic
Jan 2026 177d
ArTT Augments and Buttresses and Bone Screws
K251718 · LPH Prosthesis, Hip,... · Orthopedic
Aug 2025 86d
SMR Reverse HP Shoulder System
K243826 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2025 203d
Physica System (Physica CR Porous Femoral components)
K250980 · MBH Prosthesis, Knee,... · Orthopedic
May 2025 52d
Physica Porous Femoral Components
K243615 · MBH Prosthesis, Knee,... · Orthopedic
Dec 2024 26d
AMF TT Cones
K234011 · JWH Prosthesis, Knee,... · Orthopedic
Jan 2024 30d
PRIMA Humeral System; PRIMA TT Glenoid
K233712 · MBF Prosthesis, Shoulder,... · Orthopedic
Jan 2024 52d
SMR Hybrid Glenoid System
K231099 · MBF Prosthesis, Shoulder,... · Orthopedic
Dec 2023 247d
MINIMA S System
K231925 · LZO Prosthesis, Hip,... · Orthopedic
Jul 2023 11d
SMR Stemless Anatomic
K221758 · PKC Prosthesis, Total... · Orthopedic
Mar 2023 274d
SMR Shoulder System
K223876 · MBF Prosthesis, Shoulder,... · Orthopedic
Feb 2023 42d
Smart SPACE Shoulder Planner and 3D Positioners
K222405 · QHE Shoulder Arthroplasty... · Orthopedic
Dec 2022 133d
TEMA Elbow system - Line extension
K222807 · JDB Prosthesis, Elbow,... · Orthopedic
Oct 2022 40d
PRIMA TT Glenoid
K222427 · MBF Prosthesis, Shoulder,... · Orthopedic
Oct 2022 56d
SMR Reverse Liner
K220792 · MBF Prosthesis, Shoulder,... · Orthopedic
May 2022 62d
PRIMA Humeral System and SMR Glenosphere ?42
K212800 · PHX Shoulder Prosthesis,... · Orthopedic
Feb 2022 176d
Physica system
K213381 · JWH Prosthesis, Knee,... · Orthopedic
Dec 2021 65d
Bone Screws dia. 5,0 mm
K210717 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2021 124d
Physica system
K210554 · MBH Prosthesis, Knee,... · Orthopedic
Apr 2021 40d
LimaCorporate Kirschner Wire
K203475 · HTY Pin, Fixation, Smooth · Orthopedic
Feb 2021 72d
SMR 140? Reverse Humeral Body
K201905 · MBF Prosthesis, Shoulder,... · Orthopedic
Dec 2020 161d
Physica system
K201084 · MBH Prosthesis, Knee,... · Orthopedic
Dec 2020 235d
SMR TT Augmented Glenoid System
K200171 · PHX Shoulder Prosthesis,... · Orthopedic
Nov 2020 301d
Delta Multihole TT Pro Acetabular System
K200656 · LPH Prosthesis, Hip,... · Orthopedic
Jul 2020 118d
AMF Revision TT Cones
K200653 · JWH Prosthesis, Knee,... · Orthopedic
May 2020 56d
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