ClearanceBrief
Panels › Neurology › Product code OLO · Class 2

Orthopedic Stereotaxic Instrument

Regulation 882.4560

48510(k)s in 12 months (444 all time)
13recalls in 12 months (115 all time)
113recalls that name a 510(k)
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Top companies in OLO

DateFirm and productCodeLinked 510(k)
Oct 16, 2026Think Surgical, Inc.
Think Surgical Square Driver REF: 109126
Open, Classified
OLOK261024
Oct 7, 2026Intellijoint Surgical, Inc.
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
Open, Classified
OLOK191507
Sep 2, 2026Medos International Sarl
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Open, Classified
OLOK233228
Jul 9, 2026Think Surgical, Inc.
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumenta
Open, Classified
OLOK260010
Jun 2, 2026Kico Knee Innovation Company
Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C
Open, Classified
OLOK203115
Jun 2, 2026Kico Knee Innovation Company
Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-2
Open, Classified
OLOK203115
Mar 24, 2026Orthalign, Inc
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Open, Classified
OLOK200892
Mar 24, 2026Orthalign, Inc
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Open, Classified
OLOK200892
Mar 18, 2026Howmedica Osteonics Corp.
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Open, Classified
OLOK220459
K241011
Feb 11, 2026Alphatec Spine, Inc.
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in sur
Open, Classified
OLOK223765
Feb 11, 2026Alphatec Spine, Inc.
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in sur
Open, Classified
OLOK223765
Jan 16, 2026Mazor Robotics Ltd
Mazor X robotic guidance system REF: TPL0059
Open, Classified
OLOK230064
Dec 17, 2025SEASPINE ORTHOPEDICS CORPORATION
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-4001
Open, Classified
OLOK172517
Sep 22, 2025ORTOMA AB
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code:
Open, Classified
OLOK232140
K250086
May 13, 2025Augmedics Ltd.
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle scre
Open, Classified
OLOK211188
Apr 8, 2025Tornier S.A.S.
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Open, Classified
OLOK222510
Apr 8, 2025Tornier S.A.S.
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoul
Open, Classified
OLOK222510
Jan 27, 2025Medtronic Navigation, Inc.
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove
Open, Classified
OLOK131425
Jan 10, 2025Tornier S.A.S.
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Open, Classified
OLOK222510
Oct 10, 2024Medtronic Navigation, Inc.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in
Open, Classified
OLOK201189
Oct 9, 2024Howmedica Osteonics Corp.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Open, Classified
OLOK093425
Sep 16, 2024Mazor Robotics Ltd
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Open, Classified
OLOK230064
Jun 11, 2024Blue Belt Technologies, Inc
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anat
Open, Classified
OLOK240139
May 28, 2024Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + T
Open, Classified
OLOK172301
K193515 +1
May 28, 2024Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.
Open, Classified
OLOK172301
K193515 +1
May 28, 2024Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3
Open, Classified
OLOK172301
K193515 +1
May 28, 2024Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.
Open, Classified
OLOK172301
K193515 +1
May 28, 2024Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 +
Open, Classified
OLOK172301
K193515 +1
May 28, 2024Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.
Open, Classified
OLOK172301
K193515 +1
Mar 20, 2024Think Surgical, Inc.
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Open, Classified
OLOK230202
Feb 7, 2024Globus Medical, Inc.
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Open, Classified
OLOK171651
Jan 18, 2024Globus Medical, Inc.
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Open, Classified
OLOK211616
Jan 11, 2024Blue Belt Technologies, Inc
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Open, Classified
OLOK231963
Jan 10, 2024Medtronic Navigation, Inc.
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Open, Classified
OLOK131425
Jan 10, 2024Medtronic Navigation, Inc.
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Open, Classified
OLOK131425
Oct 12, 2023Mazor Robotics Ltd
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Open, Classified
OLOK203005
Oct 5, 2023Blue Belt Technologies, Inc
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Open, Classified
OLOK231963
Aug 9, 2023Medtronic Sofamor Danek USA, Inc
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Open, Classified
OLOK140454
Jun 30, 2023Exactech, Inc.
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Open, Classified
OLOK173372
K213546
Mar 28, 2023Brainlab AG
Cirq Arm System 2.0
Open, Classified
OLOK222966
Feb 3, 2023NuVasive Inc
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Open, Classified
OLOK210574
Dec 3, 2022Medacta Usa Inc
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Terminated
OLOK210153
Nov 8, 2022Alphatec Spine, Inc.
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15 TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO
Open, Classified
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