TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2014	245	245
2015	466	466
2016	749	749
2017	1075	1075
2018	1233	1233
2019	1585	1585
2020	2744	2744
2021	1696	1696
2022	1568	1576
2023	1491	1491
2024	1395	1395

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1684	1684
Mechanical Problem	1503	1503
Material Integrity Problem	1267	1267
Insufficient Information	787	787
Use of Device Problem	731	731
Material Deformation	694	694
Device Slipped	654	654
Detachment of Device or Device Component	537	537
Fracture	527	527
Computer Software Problem	500	500
Unintended Application Program Shut Down	450	450
Imprecision	448	448
Application Program Problem: Parameter Calculation Error	444	444
Non Reproducible Results	437	437
Adverse Event Without Identified Device or Use Problem	430	430
Incorrect, Inadequate or Imprecise Result or Readings	416	416
Connection Problem	411	411
Output Problem	268	268
Device Operates Differently Than Expected	266	266
Unintended Movement	264	264
Material Twisted/Bent	226	226
Mechanical Jam	225	225
Physical Resistance/Sticking	213	213
Device-Device Incompatibility	174	174
Malposition of Device	172	172
Application Program Problem	160	160
Human-Device Interface Problem	157	157
Residue After Decontamination	152	152
Positioning Problem	145	145
Defective Component	128	128
Material Fragmentation	121	121
Bent	116	116
Display or Visual Feedback Problem	113	113
Solder Joint Fracture	110	110
Loose or Intermittent Connection	108	108
Overheating of Device	104	104
Failure to Calibrate	103	103
Mechanics Altered	98	98
Disassembly	91	91
Positioning Failure	91	91
Electrical /Electronic Property Problem	90	90
Intermittent Continuity	88	88
Appropriate Term/Code Not Available	83	83
Premature Separation	80	80
Improper or Incorrect Procedure or Method	72	72
Noise, Audible	72	72
Device Sensing Problem	71	71
Device Displays Incorrect Message	69	69
Intermittent Communication Failure	68	68
Application Program Freezes, Becomes Nonfunctional	67	67

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5854	5862
No Known Impact Or Consequence To Patient	4203	4203
No Patient Involvement	1532	1532
No Consequences Or Impact To Patient	1374	1374
Injury	348	348
Unspecified Tissue Injury	203	203
Foreign Body In Patient	198	198
Spinal Column Injury	192	192
Pain	164	164
Insufficient Information	157	157
Bone Fracture(s)	107	107
No Information	103	103
Device Embedded In Tissue or Plaque	95	95
Tissue Damage	90	90
No Code Available	88	88
Unspecified Infection	56	56
Discomfort	53	53
Iatrogenic Source	51	51
Laceration(s)	48	48
Nerve Damage	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Failure of Implant	28	28
Joint Laxity	26	26
Unspecified Nervous System Problem	26	26
Muscle Weakness	22	22
Cerebrospinal Fluid Leakage	21	21
Inadequate Osseointegration	18	18
Hemorrhage/Bleeding	18	18
Not Applicable	16	16
Joint Dislocation	14	14
Loss of Range of Motion	14	14
Hip Fracture	13	13
Ambulation Difficulties	13	13
Post Operative Wound Infection	13	13
Numbness	11	11
Deformity/ Disfigurement	11	11
Fibrosis	9	9
Perforation	9	9
Wound Dehiscence	8	8
Complaint, Ill-Defined	8	8
Damage to Ligament(s)	7	7
Spinal Cord Injury	7	7
Neuropathy	6	6
Muscle/Tendon Damage	6	6
Hematoma	6	6
Fall	6	6
Paralysis	6	6
Inflammation	5	5
Missing Value Reason	5	5
Paresis	5	5

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