Medical Device Manufacturer · US , Beverly , MA

Tornier, Inc.

51 submissions · 51 cleared · Since 2000
51
Total
51
Cleared
0
Denied

Tornier, Inc. — FDA 510(k) Submissions

Tornier, Inc. has submitted 51 FDA 510(k) premarket notifications since 2000, of which 51 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented, Shoulder Prosthesis, Reverse Configuration, Fastener, Fixation, Nondegradable, Soft Tissue, Prosthesis, Elbow, Semi-constrained, Cemented, Plate, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

51 devices
1–25 of 51
Tornier Perform? Reversed Monopost Glenoid (Perform Mono)
K252788 · PHX Shoulder Prosthesis,... · Orthopedic
Jan 2026 128d
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
K251686 · KWT Prosthesis, Shoulder,... · Orthopedic
Oct 2025 150d
Tornier Humeral Nail and Tornier Long Humeral Nail
K230352 · HSB Rod, Fixation,... · Orthopedic
Oct 2023 264d
Tornier Perform Humeral System ? Fracture
K220914 · PHX Shoulder Prosthesis,... · Orthopedic
Oct 2022 198d
Tornier Perform Humeral System ? Stemless
K220418 · PKC Prosthesis, Total... · Orthopedic
Sep 2022 212d
Tornier Perform? Patient-Matched Primary Reversed Glenoid and BLUEPRINT? Patient Specific Instrumentation
K211359 · PHX Shoulder Prosthesis,... · Orthopedic
Nov 2021 193d
Tomier Perform? Reversed Glenoid Cannulated Glenospheres
K213124 · PHX Shoulder Prosthesis,... · Orthopedic
Oct 2021 29d
PERFORM Humeral System ? Stem
K201315 · PAO Prosthesis, Shoulder,... · Orthopedic
Sep 2020 116d
LATITUDE EV? Total Elbow Arthroplasty
K193247 · JDB Prosthesis, Elbow,... · Orthopedic
Aug 2020 254d
ORTHOLOC? SPS Shoulder Plating System
K191711 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2019 21d
AEQUALIS FLEX REVIVE Shoulder System
K191318 · KWS Prosthesis, Shoulder,... · Orthopedic
Jun 2019 30d
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · PHX Shoulder Prosthesis,... · Orthopedic
Jan 2019 30d
LATITUDE EV Total Elbow Arthroplasty
K182461 · JDB Prosthesis, Elbow,... · Orthopedic
Dec 2018 108d
ORTHOLOC SPS Shoulder Plating System
K181587 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2018 112d
Aequalis Flex Revive Shoulder System
K181420 · KWS Prosthesis, Shoulder,... · Orthopedic
Sep 2018 112d
Latitude EV Total Elbow Arthroplasty
K171010 · JDB Prosthesis, Elbow,... · Orthopedic
Aug 2017 149d
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · PHX Shoulder Prosthesis,... · Orthopedic
Nov 2016 144d
Aequalis PerFORM+ Shoulder System
K160975 · KWS Prosthesis, Shoulder,... · Orthopedic
Jun 2016 64d
ForeFoot STP System
K150871 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2015 125d
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K150715 · MBI Fastener, Fixation,... · Orthopedic
Jul 2015 131d
Aequalis PerFORM+ Shoulder System
K150583 · KWS Prosthesis, Shoulder,... · Orthopedic
Apr 2015 45d
Simpliciti Shoulder System
K143552 · PKC Prosthesis, Total... · Orthopedic
Mar 2015 79d
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · PHX Shoulder Prosthesis,... · Orthopedic
Jun 2014 57d
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · MBI Fastener, Fixation,... · Orthopedic
Apr 2014 113d
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
K133376 · HSB Rod, Fixation,... · Orthopedic
Dec 2013 31d
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