Company · US
Tornier, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.
96510(k) clearances (2 in 12 months)
20recalls (2 in 12 months)
19recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 30 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 21 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 |
| HRS | Plate, Fixation, Bone | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 |
| FTL | Mesh, Surgical, Polymeric | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 3 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 |
| NWJ | Suture, Recombinant Technology | 3 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 3 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 |
| HWC | Screw, Fixation, Bone | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | 2 |
| HTW | Bit, Drill | 1 |
| HTZ | Instrument, Cutting, Orthopedic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 2026 | K260721 | Tornier Perform Advanced Glenoid Tornier, Inc. | KWS |
| Jan 8, 2026 | K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) Tornier, Inc. | PHX |
| Oct 30, 2025 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) Tornier, Inc. | KWT |
| Oct 31, 2023 | K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail Tornier, Inc. | HSB |
| Oct 14, 2022 | K220914 | Tornier Perform Humeral System Fracture Tornier, Inc. | PHX |
| Sep 14, 2022 | K220418 | Tornier Perform Humeral System Stemless Tornier, Inc. | PKC |
| Nov 12, 2021 | K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation Tornier, Inc. | PHX |
| Oct 26, 2021 | K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres Tornier, Inc. | PHX |
| Sep 11, 2020 | K201315 | PERFORM Humeral System Stem Tornier, Inc. | PAO |
| Aug 5, 2020 | K193247 | LATITUDE EV Total Elbow Arthroplasty Tornier, Inc. | JDB |
| Jul 17, 2019 | K191711 | ORTHOLOC SPS Shoulder Plating System Tornier, Inc. | HRS |
| Jun 14, 2019 | K191318 | AEQUALIS FLEX REVIVE Shoulder System Tornier, Inc. | KWS |
| Jan 30, 2019 | K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid Tornier, Inc. | PHX |
| Dec 27, 2018 | K182461 | LATITUDE EV Total Elbow Arthroplasty Tornier, Inc. | JDB |
| Oct 5, 2018 | K181587 | ORTHOLOC SPS Shoulder Plating System Tornier, Inc. | HRS |
| Sep 20, 2018 | K181420 | Aequalis Flex Revive Shoulder System Tornier, Inc. | KWS |
| Aug 31, 2017 | K171010 | Latitude EV Total Elbow Arthroplasty Tornier, Inc. | JDB |
| Nov 15, 2016 | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid Tornier, Inc. | PHX |
| Jun 10, 2016 | K160975 | Aequalis PerFORM+ Shoulder System Tornier, Inc. | KWS |
| Aug 4, 2015 | K150871 | ForeFoot STP System Tornier, Inc. | HWC |
| Jul 28, 2015 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors Tornier, Inc. | MBI |
| Apr 23, 2015 | K150583 | Aequalis PerFORM+ Shoulder System Tornier, Inc. | KWS |
| Mar 4, 2015 | K143552 | Simpliciti Shoulder System Tornier, Inc. | PKC |
| Jun 18, 2014 | K141029 | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM Tornier, Inc. | PHX |
| Apr 4, 2014 | K133777 | TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR Tornier, Inc. | MBI |
| Dec 5, 2013 | K133376 | AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT Tornier, Inc. | HSB |
| Sep 19, 2013 | K132632 | TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES Tornier, Inc. | MBI |
| May 13, 2013 | K122635 | TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR Tornier, Inc. | MAI |
| Apr 4, 2013 | K130422 | PHANTOM FIBER BIOFIBER SUTURE Tornier, Inc. | NWJ |
| Sep 17, 2012 | K122487 | BIOFIBER SYTURE Tornier, Inc. | NWJ |
| Jul 25, 2012 | K120262 | HLS UNI EVOLUTION & U-KNEETEC Tornier, Inc., FR | HSX |
| Jul 5, 2012 | K120739 | AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM Tornier, Inc. | PHX |
| Jun 20, 2012 | K121493 | ASCEND SHOULDER SYSTEM Tornier, Inc. | KWS |
| Apr 13, 2012 | K120794 | ASCEND SHOULDER SYSTEM Tornier, Inc. | KWS |
| Mar 13, 2012 | K112144 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS Tornier, FR | PHX |
| Mar 9, 2012 | K113413 | ASCEND SHOULDER SYSTEM Tornier, Inc. | KWS |
| Feb 23, 2012 | K111970 | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT Tornier, FR | KRR |
| Jan 25, 2012 | K111337 | TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD Tornier, Inc. | FTL |
| Nov 3, 2011 | K111902 | AEQUALIS SHOULDER SYSTEM Tornier, FR | KWS |
| Oct 11, 2011 | K112615 | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM Tornier, Inc. | PHX |
| Jun 14, 2011 | K110599 | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM Tornier, Inc. | PHX |
| Jun 2, 2011 | K110773 | TORNIER INSITE FT SUTURE ANCHOR Tornier, Inc. | MBI |
| May 10, 2011 | K102788 | TORNIER BIOFIBER SCAFFOLD Tornier, Inc. | FTL |
| May 5, 2011 | K094013 | HLS KNEETEC SYSTEM Tornier, FR | JWH |
| Apr 27, 2011 | K110865 | AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM Tornier, Inc. | KWS |
| Apr 5, 2011 | K103262 | QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM Tornier, Inc. | MBI |
| Jan 31, 2011 | K102924 | AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM Tornier, Inc. | KWS |
| Nov 9, 2010 | K103007 | AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM Tornier, Inc. | KWS |
| Jun 29, 2010 | K100562 | LATITUDE ELBOW PROSTHESIS Tornier, Inc. | JDB |
| May 6, 2010 | K100142 | AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier, FR | PHX |
Newest 50 of 96.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2026 | Tornier, Inc Tornier HRS Max parts:
1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101
2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102
3. TORNIER HRS Max Trial, Cat. Open, Classified |
KWS | K251686 |
| Feb 2, 2026 | Tornier, Inc TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 Open, Classified |
KWS | K161742 |
| Apr 22, 2025 | Tornier, Inc stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented Open, Classified |
JDB | K100562 |
| Sep 27, 2024 | Tornier, Inc Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty Open, Classified |
PAO | K201315 |
| Sep 16, 2024 | Tornier, Inc stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder Open, Classified |
PKC | K220418 |
| Jan 19, 2024 | Tornier, Inc Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. Open, Classified |
PHX | K183696 |
| Oct 13, 2023 | Tornier, Inc stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 Open, Classified |
PHX | K161742 |
| Jun 28, 2023 | Tornier, Inc AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 Open, Classified |
KWS | K191318 |
| Jun 28, 2023 | Tornier, Inc AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 Open, Classified |
KWS | K191318 |
| May 3, 2022 | Tornier, Inc Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit Open, Classified |
LXH | K161742 |
| May 28, 2021 | Tornier, Inc Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile
Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. Terminated |
KWS | K122698 |
| Oct 18, 2019 | Tornier, Inc Aequalis Ascend Flex Humeral Stem:
Part Number UDI
DWF601A 3700386944475
DWF601B 3700386944482
DWF601C 3700386944499
DWF602A 3700386944505
DWF602B 3700386944512
DWF602C 3700386944529
DWF603A 370038694 Terminated |
PHX | K122698 |
| Mar 26, 2018 | Tornier, Inc AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140
Product Usage:
The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures o Terminated |
HTW | K082754 |
| Feb 8, 2018 | Tornier, Inc Fornier Phantom Fiber(TM) Sutures:
Item Number Description
SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES
SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES
SMP00 Terminated |
NWJ | K130422 |
| Sep 19, 2016 | Tornier, Inc Aequalis Fx2 implant parts and instrument trays.
Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B Terminated |
KWS | K141345 K152966 |
| Aug 26, 2015 | Tornier, Inc Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile.
Orthopedic Manual Surgical Instrument Terminated |
HSN | K130533 |
| Jul 29, 2015 | Tornier, Inc Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument. Terminated |
HSB | K082754 |
| Sep 13, 2013 | Tornier, Inc AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument Terminated |
HTZ | None listed |
| Aug 29, 2011 | Tornier, Inc Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA.
The Tornier In. Latitude Elbow Prosthesis Terminated |
JDB | K100562 |
| Nov 24, 2009 | Tornier, Inc. Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435.
The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial Terminated |
KWH | K023531 |