|
Device |
orthopedic stereotaxic instrument |
Definition |
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW. |
Product Code | OLO |
Regulation Number |
882.4560
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
7D SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
7D SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
AESCULAP IMPLANT SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AESCULAP IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALPHATEC SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ASTURA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AUGMEDICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUGMEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BLUE BELT TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLUE BELT TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
15
|
BLUE ORTHO |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
BRAINLAB AG |
|
SUBSTANTIALLY EQUIVALENT
|
19
|
BRAINLAB, AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICE SPINE, LP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICESPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CLARIANCE, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMERGE AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CORIN LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORIN USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORIN USA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CRYPTYCH PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CTL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUREXO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CURITEVA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEGEN MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEPUY SYNTHES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ECENTIAL ROBOTICS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ENZTEC LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVERGREEN ORTHOPEDIC RESEARCH LAB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FIAGON GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION ROBOTICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENESYS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GLOBUS MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HANGZHOU LANCET ROBOTICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICOTEC AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOSYS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSIGHT MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSIGHT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTAI TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRITY IMPLANTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTELLIJOINT SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
IZI MEDICAL PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOIMAX GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KALITEC DIRECT, LLC DOING BUSINESS AS KALITEC MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KICO KNEE INNOVATION COMPANY PTY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KICO KNEE INNOVATION COMPANY PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAKO SURGICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
15
|
MAKO SURGICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MAZOR ROBOTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAZOR ROBOTICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL, SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDIVIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDOS INTERNATIONAL SÀRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL, SARL |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MEDTECH S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC NAVIGATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDTRONIC NAVIGATION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC POWERED SURGICAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
MEDTRONIC SOFAMOR DANEK, USA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK, USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT NAVIBOT INTERNATIONAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAVBIT PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAVISWISS AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVARAD CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
OMNLLIFE SCIENCE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ONPOINT SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHALIGN INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHALIGN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ORTHALIGN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOKEY ITALIA S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIATRICS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOSOFT D/B/A ZIMMER CAS |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ORTHOSOFT INC (D/B/A ZIMMER CAS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOSOFT INC. (D/B/A ZIMMER CAS) |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOSOFT, INC (D/B/A ZIMMER CAS) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOSOFT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTOMA AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OSSEUS FUSION SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PATHKEEPER SURGICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PINSCO INC. DBA B & L ENGINEERING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIXEE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
POINT ROBOTICS MEDTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
POLARISAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRACTICAL NAVIGATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRAXIM MEDIVISION, SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PREMIA SPINE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROPRIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REMEX MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
REMEX MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REPUBLIC SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SI-BONE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SILONY MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
SMITH & NEWPHEW, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEART SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINECRAFT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STANMORE IMPLANTS WORLDWIDE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORPORATE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STRYKER LEIBINGER GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
STRYKER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGALIGN SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SURGICAL THEATER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THINK SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
THINK SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
TORNIER SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULRICH MEDICAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER BIOMET SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZIMMER CAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMVIE (ZIMMER BIOMET SPINE, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Alphatec Spine, Inc. |
II |
Nov-08-2022 |
2 |
Blue Belt Technologies MN |
II |
May-09-2014 |
3 |
Blue Belt Technologies, Inc |
II |
Jun-11-2024 |
4 |
Blue Belt Technologies, Inc |
II |
Jan-11-2024 |
5 |
Blue Belt Technologies, Inc |
II |
Oct-05-2023 |
6 |
Blue Ortho |
II |
Oct-23-2020 |
7 |
Blue Ortho |
II |
Feb-11-2020 |
8 |
Brainlab AG |
II |
Mar-28-2023 |
9 |
Brainlab AG |
II |
Aug-29-2020 |
10 |
Brainlab AG |
II |
Aug-13-2020 |
11 |
Brainlab AG |
II |
Oct-11-2018 |
12 |
Brainlab AG |
II |
Feb-26-2015 |
13 |
DePuy Orthopaedics, Inc. |
II |
May-02-2022 |
14 |
Exactech, Inc. |
II |
Jun-30-2023 |
15 |
Exactech, Inc. |
II |
Jan-18-2018 |
16 |
Globus Medical, Inc. |
II |
Feb-07-2024 |
17 |
Globus Medical, Inc. |
I |
Jan-18-2024 |
18 |
Intellijoint Surgical, Inc. |
II |
Mar-23-2020 |
19 |
Intellijoint Surgical, Inc. |
II |
Aug-08-2019 |
20 |
K2M, Inc |
II |
Oct-07-2019 |
21 |
Mako Surgical Corporation |
II |
Sep-09-2022 |
22 |
Mako Surgical Corporation |
II |
Nov-19-2020 |
23 |
Mako Surgical Corporation |
II |
Jul-31-2020 |
24 |
Mako Surgical Corporation |
II |
Jun-16-2019 |
25 |
Mako Surgical Corporation |
II |
Sep-15-2018 |
26 |
Mako Surgical Corporation |
II |
Aug-24-2018 |
27 |
Mako Surgical Corporation |
II |
Aug-14-2018 |
28 |
Mako Surgical Corporation |
II |
May-04-2018 |
29 |
Mako Surgical Corporation |
II |
Sep-13-2017 |
30 |
Mako Surgical Corporation |
II |
Jul-18-2017 |
31 |
Mako Surgical Corporation |
II |
Mar-07-2017 |
32 |
Mako Surgical Corporation |
II |
Feb-11-2017 |
33 |
Mako Surgical Corporation |
II |
Apr-29-2016 |
34 |
Mako Surgical Corporation |
II |
Apr-28-2016 |
35 |
Mako Surgical Corporation |
II |
Apr-18-2016 |
36 |
Mako Surgical Corporation |
II |
Nov-05-2015 |
37 |
Mako Surgical Corporation |
II |
Feb-19-2015 |
38 |
Mako Surgical Corporation |
II |
Dec-18-2014 |
39 |
Mako Surgical Corporation |
II |
Nov-19-2012 |
40 |
Mako Surgical Corporation |
II |
Nov-01-2011 |
41 |
Mazor Robotics Ltd |
II |
Sep-16-2024 |
42 |
Mazor Robotics Ltd |
II |
Oct-12-2023 |
43 |
Mazor Robotics Ltd |
II |
Dec-20-2019 |
44 |
Medacta Usa Inc |
II |
Dec-03-2022 |
45 |
Medtronic Navigation, Inc. |
II |
Jan-10-2024 |
46 |
Medtronic Navigation, Inc. |
II |
Jun-09-2020 |
47 |
Medtronic Navigation, Inc. |
II |
Apr-10-2020 |
48 |
Medtronic Navigation, Inc. |
II |
Dec-19-2019 |
49 |
Medtronic Navigation, Inc. |
II |
Sep-21-2017 |
50 |
Medtronic Navigation, Inc. |
II |
Aug-02-2016 |
51 |
Medtronic Navigation, Inc. |
II |
Sep-30-2015 |
52 |
Medtronic Sofamor Danek USA, Inc |
II |
Aug-09-2023 |
53 |
NuVasive Inc |
III |
Feb-03-2023 |
54 |
OMNI LIFE SCIENCE |
III |
Nov-17-2016 |
55 |
OMNIlife science Inc. |
II |
Jun-04-2019 |
56 |
Orthosoft, Inc. dba Zimmer CAS |
II |
Mar-03-2022 |
57 |
Orthosoft, Inc. dba Zimmer CAS |
II |
Apr-26-2017 |
58 |
Orthosoft, Inc. dba Zimmer CAS |
II |
Apr-19-2017 |
59 |
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
II |
Nov-02-2020 |
60 |
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
II |
Oct-31-2020 |
61 |
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
II |
Oct-27-2020 |
62 |
Smith & Nephew Inc |
II |
Nov-18-2010 |
63 |
Smith & Nephew, Inc. |
II |
Apr-01-2020 |
64 |
Stryker Orthopaedics |
II |
May-28-2024 |
65 |
Think Surgical, Inc. |
II |
Mar-20-2024 |
66 |
Think Surgical, Inc. |
II |
Aug-06-2018 |
67 |
Zimmer Biomet, Inc. |
II |
Feb-16-2018 |
68 |
Zimmer Biomet, Inc. |
II |
Nov-28-2017 |
69 |
Zimmer Biomet, Inc. |
II |
Mar-27-2017 |
70 |
Zimmer CAS |
II |
Jun-02-2015 |
|
|
|
|