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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurological stereotaxic instrument
Regulation Description Stereotaxic instrument.
Product CodeHAW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
7D SURGICAL ULC
  SUBSTANTIALLY EQUIVALENT 1
BAYER MEDICAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAIN NAVI BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 9
CLARONAV
  SUBSTANTIALLY EQUIVALENT 1
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 10
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
KOH YOUNG TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LOCALITE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDIVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.S
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 5
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
PHASOR HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
SINOVATION (BEIJING) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERATAXIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 3480 3481
2021 2827 2830
2022 1929 1966
2023 2510 2535
2024 3755 3760
2025 3484 3484
2026 688 688

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 3046 3060
Mechanical Problem 2739 2741
Application Program Problem 2533 2540
Device Sensing Problem 2502 2511
Imprecision 1870 1889
Display or Visual Feedback Problem 1634 1637
Incorrect, Inadequate or Imprecise Result or Readings 1607 1615
Communication or Transmission Problem 1349 1350
Material Integrity Problem 1117 1123
Human-Device Interface Problem 958 965
Adverse Event Without Identified Device or Use Problem 952 955
Environmental Compatibility Problem 890 892
Use of Device Problem 731 733
Connection Problem 687 687
Computer Software Problem 352 352
Unexpected Shutdown 347 348
Electrical /Electronic Property Problem 227 227
Output Problem 190 191
Incorrect Measurement 163 163
Unintended Application Program Shut Down 151 152
Power Problem 140 140
Mechanical Jam 88 88
Material Fragmentation 82 82
Fracture 81 82
Failure to Power Up 80 80
Computer Operating System Problem 74 74
Insufficient Information 72 73
No Device Output 69 71
Failure to Read Input Signal 62 62
Break 59 60
Activation, Positioning or Separation Problem 58 58
Excessive Heating 57 57
Delayed Program or Algorithm Execution 56 56
Improper or Incorrect Procedure or Method 56 56
Patient Data Problem 51 51
Mechanics Altered 47 47
Unintended Collision 38 38
Malposition of Device 37 37
Naturally Worn 33 33
Material Twisted/Bent 32 32
Data Problem 32 33
Failure to Shut Off 31 31
Positioning Problem 25 27
Image Display Error/Artifact 23 23
Deformation Due to Compressive Stress 22 22
Audible Prompt/Feedback Problem 22 22
Unintended Movement 21 21
Device Handling Problem 20 20
Material Deformation 19 19
Detachment of Device or Device Component 18 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15208 15270
No Patient Involvement 1449 1449
No Known Impact Or Consequence To Patient 1233 1233
No Consequences Or Impact To Patient 293 293
Unspecified Tissue Injury 248 249
Insufficient Information 161 163
Hemorrhage/Bleeding 117 117
Intracranial Hemorrhage 80 80
Cerebrospinal Fluid Leakage 80 81
Unspecified Infection 73 73
Unspecified Nervous System Problem 71 72
No Code Available 60 60
Tissue Damage 53 53
Hematoma 44 44
Muscle Weakness 42 43
Pain 41 41
Dysphasia 34 34
Post Operative Wound Infection 32 32
Convulsion/Seizure 29 29
Paralysis 27 28
Headache 22 22
Nerve Damage 22 22
Cognitive Changes 21 22
Paresis 21 22
Foreign Body In Patient 20 21
Swelling/ Edema 19 19
Device Embedded In Tissue or Plaque 18 18
Ambulation Difficulties 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Bacterial Infection 17 17
Bone Fracture(s) 16 16
Numbness 16 17
Hydrocephalus 16 16
Thrombosis/Thrombus 13 13
Visual Impairment 13 13
Meningitis 13 13
Paresthesia 13 14
Loss of Range of Motion 12 12
Memory Loss/Impairment 10 10
Brain Injury 10 10
Perforation 10 10
No Information 9 9
Spinal Column Injury 9 9
Pleural Effusion 8 8
Abscess 8 8
Urinary Tract Infection 8 8
Cardiac Arrest 8 8
Dysphagia/ Odynophagia 7 7
Fever 7 7
Cancer 7 8

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG II Oct-06-2020
2 Elekta Inc II Apr-29-2020
3 Elekta Instrument AB I Nov-06-2024
4 Elekta Instrument AB I Apr-16-2024
5 Elekta Instrument AB II Mar-30-2023
6 Elekta Instrument AB II Jul-10-2020
7 Elekta, Inc. II Apr-29-2026
8 Elekta, Inc. II Nov-05-2025
9 FHC, Inc. I Nov-08-2024
10 Globus Medical, Inc. II Feb-06-2024
11 Howmedica Osteonics Corp. II Dec-19-2025
12 MEDTECH SAS I Oct-25-2021
13 MEDTECH SAS II Feb-11-2020
14 Medtronic Navigation, Inc. I May-09-2024
15 Medtronic Navigation, Inc. I Nov-10-2023
16 Medtronic Navigation, Inc. I Jun-02-2023
17 Medtronic Navigation, Inc. I Jun-02-2023
18 Medtronic Navigation, Inc. II Jan-30-2023
19 Medtronic Navigation, Inc. I Dec-22-2021
20 Medtronic Navigation, Inc. II Dec-22-2021
21 Medtronic Navigation, Inc. II Jul-27-2020
22 Medtronic Navigation, Inc. I May-18-2020
23 Medtronic Xomed, Inc. II Oct-21-2021
24 Navinetics Inc II Apr-04-2024
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