Definition: Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code HAW.
| Device Type ID | 4456 |
| Device Name | Orthopedic Stereotaxic Instrument |
| Physical State | Device Consists Of Camera, Computer, Various Shaped Tracking Arrays, Computer Interface For Commmunication Between User And Device. |
| Technical Method | User Loads Computer Software Pre-Op To Plan Surgery Procedure, Then Registers The Patient Anatomy During Surgery To Allow Software To Track Patient Anatomy, Implants, And Surgical Tools In Real Time/space. |
| Target Area | Orthopedic Joints And Spinal Procedures Where Tracking Of Instrumentation Is Desired. |
| Regulation Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4456 |
| Device | Orthopedic Stereotaxic Instrument |
| Product Code | OLO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AESCULAP IMPLANT SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ALPHATEC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALPHATEC HOLDINGS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASTURA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BLUE BELT TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BLUE ORTHO | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CRYPTYCH PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EVERGREEN ORTHOPEDIC RESEARCH LAB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INTELLIJOINT SURGICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
K2M | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MAKO SURGICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
MAKO SURGICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MAZOR ROBOTICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAZOR ROBOTICS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MEDOS INTERNATIONAL SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDOS INTERNATIONAL, SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTECH S.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
MEDTRONIC NAVIGATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHALIGN, INC | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SI-BONE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPINE WAVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEOLOGY INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINEOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 13 | |
STRYKER CORPORATE | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
THINK SURGICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Mechanical Problem | 758 |
Material Deformation | 631 |
Break | 582 |
Insufficient Information | 510 |
Material Integrity Problem | 489 |
Clamp | 299 |
Device Operates Differently Than Expected | 240 |
Computer Software Problem | 222 |
Detachment Of Device Or Device Component | 193 |
Adverse Event Without Identified Device Or Use Problem | 175 |
Non Reproducible Results | 173 |
Probe | 130 |
Imprecision | 116 |
Bent | 116 |
Output Problem | 113 |
Screw | 111 |
Tip | 107 |
Disassembly | 91 |
Driver | 91 |
Use Of Device Problem | 77 |
Electrical /Electronic Property Problem | 64 |
Fracture | 63 |
Device Issue | 63 |
Device Damaged By Another Device | 61 |
Unintended Movement | 51 |
Device Displays Incorrect Message | 51 |
Connection Problem | 44 |
Communication Or Transmission Problem | 42 |
Material Twisted / Bent | 37 |
Detachment Of Device Component | 36 |
Pin | 34 |
Complete Blockage | 33 |
Washer | 32 |
Cannula | 29 |
Device Operational Issue | 28 |
Loose Or Intermittent Connection | 28 |
Device Component Or Accessory | 25 |
Device Inoperable | 24 |
Frame | 22 |
Vibration | 21 |
Temperature Problem | 21 |
Migration Or Expulsion Of Device | 20 |
Naturally Worn | 18 |
Mechanical Jam | 17 |
Screw Head | 17 |
Device Reprocessing Problem | 16 |
Handpiece | 15 |
Device Contamination With Chemical Or Other Material | 15 |
Malposition Of Device | 15 |
Positioning Problem | 14 |
Image Display Error / Artifact | 14 |
Failure To Fire | 14 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 14 |
Electrical Power Problem | 13 |
Material Fragmentation | 13 |
Calibration Problem | 12 |
Device Dislodged Or Dislocated | 12 |
Contamination During Use | 12 |
Cap | 12 |
Partial Blockage | 11 |
Computer Operating System Problem | 10 |
Unstable | 10 |
Improper Device Output | 10 |
Metal Shedding Debris | 10 |
Smoking | 9 |
Screw Tapper | 9 |
Overheating Of Device | 9 |
Noise, Audible | 8 |
Material Separation | 8 |
Motor | 8 |
Appropriate Term/Code Not Available | 8 |
Difficult To Open Or Close | 7 |
Occlusion Within Device | 7 |
Power Problem | 7 |
Improper Or Incorrect Procedure Or Method | 7 |
Human-Device Interface Problem | 7 |
Application Program Problem | 7 |
Needle | 7 |
Spring | 6 |
Locking Mechanism | 6 |
Expiration Date Error | 6 |
Misassembled | 6 |
Component Missing | 6 |
No Apparent Adverse Event | 5 |
Difficult To Remove | 5 |
Device Stops Intermittently | 5 |
Device Difficult To Setup Or Prepare | 4 |
Cannula, Inner | 4 |
Loss Of Or Failure To Bond | 4 |
Residue After Decontamination | 4 |
Failure To Power Up | 4 |
Cannula Guide | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
Unintended Arm Motion | 4 |
No Device Output | 4 |
Disconnection | 4 |
Image Orientation Incorrect | 4 |
Failure To Shut Off | 3 |
Failure To Align | 3 |
Thread | 3 |
| Total Device Problems | 6553 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Blue Belt Technologies MN | II | May-09-2014 |
| 2 | Brainlab AG | II | Oct-11-2018 |
| 3 | Brainlab AG | II | Feb-26-2015 |
| 4 | Exactech, Inc. | II | Jan-18-2018 |
| 5 | Mako Surgical Corporation | II | Sep-15-2018 |
| 6 | Mako Surgical Corporation | II | Aug-24-2018 |
| 7 | Mako Surgical Corporation | II | Aug-14-2018 |
| 8 | Mako Surgical Corporation | II | May-04-2018 |
| 9 | Mako Surgical Corporation | II | Sep-13-2017 |
| 10 | Mako Surgical Corporation | II | Jul-18-2017 |
| 11 | Mako Surgical Corporation | II | Mar-07-2017 |
| 12 | Mako Surgical Corporation | II | Feb-11-2017 |
| 13 | Mako Surgical Corporation | II | Apr-29-2016 |
| 14 | Mako Surgical Corporation | II | Apr-28-2016 |
| 15 | Mako Surgical Corporation | II | Apr-18-2016 |
| 16 | Mako Surgical Corporation | II | Nov-05-2015 |
| 17 | Mako Surgical Corporation | II | Feb-19-2015 |
| 18 | Mako Surgical Corporation | II | Dec-18-2014 |
| 19 | Medtronic Navigation, Inc. | II | Sep-21-2017 |
| 20 | Medtronic Navigation, Inc. | II | Aug-02-2016 |
| 21 | Medtronic Navigation, Inc. | II | Sep-30-2015 |
| 22 | OMNI LIFE SCIENCE | III | Nov-17-2016 |
| 23 | Orthosoft, Inc. Dba Zimmer CAS | II | Apr-26-2017 |
| 24 | Orthosoft, Inc. Dba Zimmer CAS | II | Apr-19-2017 |
| 25 | Think Surgical, Inc. | II | Aug-06-2018 |
| 26 | Zimmer Biomet, Inc. | II | Feb-16-2018 |
| 27 | Zimmer Biomet, Inc. | II | Nov-28-2017 |
| 28 | Zimmer Biomet, Inc. | II | Mar-27-2017 |
| 29 | Zimmer CAS | II | Jun-02-2015 |