Orthopedic Stereotaxic Instrument
Regulation 882.4560
47510(k)s in 12 months (443 all time)
13recalls in 12 months (115 all time)
113recalls that name a 510(k)
Top companies in OLO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | Think Surgical, Inc. Think Surgical Square Driver
REF: 109126 Open, Classified |
OLO | K261024 |
| Oct 7, 2026 | Intellijoint 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 |
OLO | K191507 |
| Sep 2, 2026 | Medos International Sarl Velys Enabling Tech Robotic-Assist Station
REF: 451611001 Open, Classified |
OLO | K233228 |
| Jul 9, 2026 | Think 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 |
OLO | K260010 |
| Jun 2, 2026 | Kico 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 |
OLO | K203115 |
| Jun 2, 2026 | Kico 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 |
OLO | K203115 |
| Mar 24, 2026 | Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7
REF:402567
component Lantern Knee System Open, Classified |
OLO | K200892 |
| Mar 24, 2026 | Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5
REF:402566
component Lantern Knee System Open, Classified |
OLO | K200892 |
| Mar 18, 2026 | Howmedica Osteonics Corp. MICS3 Angled Sagittal Saw Attachment;
Part Number: 210490 Open, Classified |
OLO | K220459 K241011 |
| Feb 11, 2026 | Alphatec 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 |
OLO | K223765 |
| Feb 11, 2026 | Alphatec 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 |
OLO | K223765 |
| Jan 16, 2026 | Mazor Robotics Ltd Mazor X robotic guidance system
REF: TPL0059 Open, Classified |
OLO | K230064 |
| Dec 17, 2025 | SEASPINE 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 |
OLO | K172517 |
| Sep 22, 2025 | ORTOMA 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 |
OLO | K232140 K250086 |
| May 13, 2025 | Augmedics 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 |
OLO | K211188 |
| Apr 8, 2025 | Tornier S.A.S. stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier 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 |
OLO | K222510 |
| Apr 8, 2025 | Tornier 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 |
OLO | K222510 |
| Apr 8, 2025 | Tornier 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 |
OLO | K222510 |
| Apr 8, 2025 | Tornier 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 |
OLO | K222510 |
| Apr 8, 2025 | Tornier 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 |
OLO | K222510 |
| Apr 8, 2025 | Tornier 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 |
OLO | K222510 |
| Jan 27, 2025 | Medtronic 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 |
OLO | K131425 |
| Jan 10, 2025 | Tornier S.A.S. Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200.
Indicated for use during Total Shoulder Arthroplasty. Open, Classified |
OLO | K222510 |
| Oct 10, 2024 | Medtronic 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 |
OLO | K201189 |
| Oct 9, 2024 | Howmedica Osteonics Corp. MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 Open, Classified |
OLO | K093425 |
| Sep 16, 2024 | Mazor Robotics Ltd Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Open, Classified |
OLO | K230064 |
| Jun 11, 2024 | Blue 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 |
OLO | K240139 |
| May 28, 2024 | Stryker 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 |
OLO | K172301 K193515 +1 |
| May 28, 2024 | Stryker 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 |
OLO | K172301 K193515 +1 |
| May 28, 2024 | Stryker 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 |
OLO | K172301 K193515 +1 |
| May 28, 2024 | Stryker 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 |
OLO | K172301 K193515 +1 |
| May 28, 2024 | Stryker 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 |
OLO | K172301 K193515 +1 |
| May 28, 2024 | Stryker 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 |
OLO | K172301 K193515 +1 |
| Mar 20, 2024 | Think Surgical, Inc. Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System Open, Classified |
OLO | K230202 |
| Feb 7, 2024 | Globus Medical, Inc. ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 Open, Classified |
OLO | K171651 |
| Jan 18, 2024 | Globus Medical, Inc. ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 Open, Classified |
OLO | K211616 |
| Jan 11, 2024 | Blue Belt Technologies, Inc CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Open, Classified |
OLO | K231963 |
| Jan 10, 2024 | Medtronic Navigation, Inc. Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Open, Classified |
OLO | K131425 |
| Jan 10, 2024 | Medtronic Navigation, Inc. Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Open, Classified |
OLO | K131425 |
| Oct 12, 2023 | Mazor Robotics Ltd MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 Open, Classified |
OLO | K203005 |
| Oct 5, 2023 | Blue 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 |
OLO | K231963 |
| Aug 9, 2023 | Medtronic Sofamor Danek USA, Inc CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K Open, Classified |
OLO | K140454 |
| Jun 30, 2023 | Exactech, Inc. Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. Open, Classified |
OLO | K173372 K213546 |
| Mar 28, 2023 | Brainlab AG Cirq Arm System 2.0 Open, Classified |
OLO | K222966 |
| Feb 3, 2023 | NuVasive Inc NuVasive MD Pulse III Multimodality System REF 1881500
Pulse Software version 369-BL.US and 369-BLN.US Open, Classified |
OLO | K210574 |
| Dec 3, 2022 | Medacta 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 |
OLO | K210153 |
| Nov 8, 2022 | Alphatec 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 |
OLO | None listed |
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