Orthopedic Stereotaxic Instrument

Device Code: 4456

Product Code(s): OLO

Definition: Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code HAW.

Device Classification Information

Device Type ID4456
Device NameOrthopedic Stereotaxic Instrument
Physical StateDevice Consists Of Camera, Computer, Various Shaped Tracking Arrays, Computer Interface For Commmunication Between User And Device.
Technical MethodUser 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 AreaOrthopedic Joints And Spinal Procedures Where Tracking Of Instrumentation Is Desired.
Regulation DescriptionStereotaxic Instrument.
Regulation Medical SpecialtyNeurology
Review PanelOrthopedic
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 Type510(k)
CFR Regulation Number882.4560 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOLO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4456
DeviceOrthopedic Stereotaxic Instrument
Product CodeOLO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionStereotaxic Instrument.
CFR Regulation Number882.4560 [🔎]
Premarket Reviews
ManufacturerDecision
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
TPLC Last Update: 2019-04-02 20:49:32

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