Orthopedic Stereotaxic Instrument
Regulation 882.4560
47510(k)s in 12 months (444 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) |
|---|---|---|---|
| Aug 8, 2022 | Mako Surgical Corporation Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System. Terminated |
OLO | K121064 |
| Mar 11, 2022 | DePuy Orthopaedics, Inc. VELYS Robotic-Assisted Solution Base
Product No.: 451570100 Terminated |
OLO | K202769 |
| Jan 7, 2022 | Orthosoft, Inc. dba Zimmer CAS NavitrackER Kit A: Knee, Model Number 20-8000-000-07, Open, Classified |
OLO | K110054 |
| Nov 19, 2020 | Mako Surgical Corporation Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the dist Completed |
OLO | K142350 |
| Nov 2, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN
26-FTAP-30-MDN
26-FTAP-35-MDN
26-FTAP-40-MDN
26-FTAP-40-MDN
26-FTAP-45-MDN
26-S-FINDER-MDN
Components of a surgical navigation de Open, Classified |
OLO | K200095 |
| Oct 27, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline TL Navigation System, Catalog Nos.
02-C-TAP-55-MDN
02-C-TAP-60-L-MDN
02-C-TAP-65-L-MDN
02-C-TAP-65-MDN
02-C-TAP-75-L-MDN
02-C-TAP-85-L-MDN
02-C-TAP-85-MDN
02-C-TAP-95-L-MDN
02-RS-INS-C-MD Terminated |
OLO | K200095 |
| Oct 27, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline MIS Navigation System Taps, Catalog Nos.
04-CANNDRILL-MDN
04-CANNTAP-40-MDN
04-CANNTAP-45-MDN
04-CANNTAP-55-MDN
04-CANNTAP-65-MDN
04-CANNTAP-75-MDN
04-CANNTAP-85-MDN
04-CTAP-TT-65-MDN
04- Terminated |
OLO | K200095 |
| Sep 11, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline MIS Navigation System Taps, Catalog numbers
04-CANNDRILL-MDN
04-CANNTAP-40-MDN
04-CANNTAP-45-MDN
04-CANNTAP-55-MDN
04-CANNTAP-65-MDN
04-CANNTAP-75-MDN
04-CANNTAP-85-MDN
04-CTAP-TT-65-MDN
Terminated |
OLO | K200095 |
| Sep 10, 2020 | Blue Ortho Instructions For Use document of the GPS Trackers. Terminated |
OLO | K193618 |
| Aug 20, 2020 | Brainlab AG Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A) Terminated |
OLO | K183605 |
| Jul 31, 2020 | Mako Surgical Corporation Mako Hip End Effector, Variable Angle
Catalog Number: 206967
GTIN:00848486022167 Terminated |
OLO | K141989 |
| Jul 16, 2020 | Brainlab AG BRAINLAB Kick 2;
Model/catalogue (article) numbers for Kick: 18170; 18070
UDI (GTIN) for Kick: 04056481006655 Terminated |
OLO | K183605 |
| Jul 16, 2020 | Brainlab AG BRAINLAB Curve;
Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905
UDI (GTIN) for Curve: 04056481138011 Terminated |
OLO | K183605 |
| Jun 9, 2020 | Medtronic Navigation, Inc. Mazor X Surgical System Positioner Type II, REF: ASM0214-02 Open, Classified |
OLO | K182077 |
| Apr 10, 2020 | Medtronic Navigation, Inc. NavLock Tracker *** Rx Only Terminated |
OLO | K171267 K182104 |
| Feb 27, 2020 | Smith & Nephew, Inc. NAVIO Soft Tissue Protector, included in instrument kits.
The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navi Terminated |
OLO | K121936 |
| Feb 11, 2020 | Intellijoint Surgical, Inc. Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-oper Terminated |
OLO | K191507 |
| Sep 22, 2019 | Blue Ortho Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty
Catalog Reference: L00002 Terminated |
OLO | K152764 |
| Aug 8, 2019 | Intellijoint Surgical, Inc. Workstation, G2, Configured (P/N 000-0241) Terminated |
OLO | K172849 |
| Jul 2, 2019 | Mazor Robotics Ltd Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 Terminated |
OLO | K182077 |
| Apr 25, 2019 | Mako Surgical Corporation 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) Terminated |
OLO | K143752 |
| Apr 25, 2019 | Mako Surgical Corporation 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) Terminated |
OLO | K143752 |
| Apr 12, 2019 | OMNIlife science Inc. OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock C Terminated |
OLO | K090953 |
| Dec 6, 2018 | Medtronic Navigation, Inc. Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 0064 Terminated |
OLO | K131425 |
| Aug 24, 2018 | Mako Surgical Corporation Stryker Mako Vizadisc Hip Procedure Tracking Kit Terminated |
OLO | K121064 |
| Aug 24, 2018 | Mako Surgical Corporation Stryker Mako Vizadisc Knee Procedure Tracking Kit Terminated |
OLO | K112507 |
| May 10, 2018 | Mako Surgical Corporation Rio System Irrigation Clip - Catalog # 111690
Product Usage:
The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the sur Terminated |
OLO | K170891 |
| Mar 30, 2018 | Think Surgical, Inc. Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428
The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty. Terminated |
OLO | None listed |
| Jan 18, 2018 | Exactech, Inc. Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool Terminated |
OLO | K162567 |
| Dec 27, 2017 | Mako Surgical Corporation Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933
Product Usage:
The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical kn Terminated |
OLO | K170581 K170584 +2 |
| Dec 1, 2017 | Mako Surgical Corporation RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements. Terminated |
OLO | K170584 K170891 |
| Aug 7, 2017 | Mako Surgical Corporation Total Hip Application (THA)
Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation an Terminated |
OLO | K121064 K141989 |
| Aug 7, 2017 | Mako Surgical Corporation Makoplasty Partial Knee Application (PKA)
Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for o Terminated |
OLO | K112507 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intende Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Double Spinous Process Clamp, Short
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigi Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Spinous Process Clamp, Short
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attac Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Spinous Process Clamp, Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attach Terminated |
OLO | K131425 |
| Jun 7, 2017 | Mako Surgical Corporation MAKO RIO Standard System, internal cPCI Card CageP/N: 201337.
Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures. Terminated |
OLO | K112507 |
| May 1, 2017 | Zimmer Biomet, Inc. ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device.
Intended for the spatial positioning and orientation of instrument holders to be used by surgeons. Terminated |
OLO | K151511 |
| Apr 26, 2017 | Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
CAS Software application intended to assist in the placement of total knee replacement components Terminated |
OLO | K110054 |
| Mar 27, 2017 | Zimmer Biomet, Inc. MEDTECH ROSA Spine 1.0.2
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments Terminated |
OLO | K151511 |
| Feb 20, 2017 | Orthosoft, Inc. dba Zimmer CAS SmartTools Knee System
Orthopedic Stereotaxic Instrument Terminated |
OLO | K122326 |
| Dec 22, 2016 | Mako Surgical Corporation MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. Terminated |
OLO | K121064 K141989 |
| Dec 2, 2016 | K2M, Inc K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor)
Product Usage:
Special Connector Instruments include an additional feature on their shafts that enable surgeo Terminated |
OLO | K171321 |
| Nov 17, 2016 | OMNI LIFE SCIENCE OMNIBotics Tracker Kit -Model: RM-10000
The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomic Terminated |
OLO | K090953 |
| Oct 27, 2016 | Brainlab AG Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Terminated |
OLO | K102990 |
| Sep 29, 2016 | Mako Surgical Corporation Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only
Product Usage:
The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures. Terminated |
OLO | K121064 |
| Jul 18, 2016 | Medtronic Navigation, Inc. Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as an aid for pr Terminated |
OLO | K131425 |
| Apr 18, 2016 | Mako Surgical Corporation Robotic Arm Interactive Orthopedic System (RIO) Terminated |
OLO | K112507 K121064 |
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