Thoracolumbosacral Pedicle Screw System

Device Code: 4644

Product Code(s): NKB

Definition: Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.

Device Classification Information

Device Type ID4644
Device NameThoracolumbosacral Pedicle Screw System
Regulation DescriptionThoracolumbosacral Pedicle Screw System.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Submission Type510(k)
CFR Regulation Number888.3070 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNKB
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4644
DeviceThoracolumbosacral Pedicle Screw System
Product CodeNKB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionThoracolumbosacral Pedicle Screw System.
CFR Regulation Number888.3070 [🔎]
Premarket Reviews
ManufacturerDecision
ACCELSPINE
 
SUBSTANTIALLY EQUIVALENT
 1
AESCULAP IMPLANT SYSTEMS, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
ALPHATEC
 
SUBSTANTIALLY EQUIVALENT
 4
ALPHATEC HOLDINGS, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
AMENDIA, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
ARTHRO-DIF
 
SUBSTANTIALLY EQUIVALENT
 1
BACK 2 BASICS DIRECT, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
BAXANO SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIEDERMANN MOTECH GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 2
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMET SPINE (AKA EBI, LLC)
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMET SPINE LLC.
 
SUBSTANTIALLY EQUIVALENT
 1
BK MEDITECH CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
BM KOREA
 
SUBSTANTIALLY EQUIVALENT
 1
CAMBER SPINE
 
SUBSTANTIALLY EQUIVALENT
 1
CAPTIVA SPINE
 
SUBSTANTIALLY EQUIVALENT
 1
CARBOFIX ORTHOPEDICS LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
CHOICE SPINE
 
SUBSTANTIALLY EQUIVALENT
 2
CHOICE SPINE, LP
 
SUBSTANTIALLY EQUIVALENT
 2
CORELINK LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CTL MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
DEGEN MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 3
DEPUY INTL., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
DEPUY SPINE, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
EBI, L.P.
 
SUBSTANTIALLY EQUIVALENT
 1
EBI, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
EISERTECH, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
EVOLUTION SPINE, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
FLOSPINE
 
SUBSTANTIALLY EQUIVALENT
 1
G SURGICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
GENESYS SPINE
 
SUBSTANTIALLY EQUIVALENT
 4
GLOBE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBUS
 
SUBSTANTIALLY EQUIVALENT
 2
GS MEDICAL CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
ICOTEC AG
 
SUBSTANTIALLY EQUIVALENT
 1
IMPLANET S.A.
 
SUBSTANTIALLY EQUIVALENT
 2
INNOVASIS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
INNOVATIVE SURGICAL DESIGNS, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
INTELLIGENT IMPLANT SYSTEMS, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
K2M
 
SUBSTANTIALLY EQUIVALENT
 1
K2M, INC.
 
SUBSTANTIALLY EQUIVALENT
 8
K2M, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
KALITEC MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
L&K BIOMED CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 5
LANTERNA MEDICAL TECHNOLOGIES
 
SUBSTANTIALLY EQUIVALENT
 2
LIFE SPINE
 
SUBSTANTIALLY EQUIVALENT
 1
LIFE SPINE, LLC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDACTA INTERNATIONAL
 
SUBSTANTIALLY EQUIVALENT
 3
MEDACTA INTERNATIONAL SA
 
SUBSTANTIALLY EQUIVALENT
 3
MEDICREA INTERNATIONAL S.A.
 
SUBSTANTIALLY EQUIVALENT
 5
MEDOS INTERNATIONAL SARL
 
SUBSTANTIALLY EQUIVALENT
 2
MEDOS INTERNATIONAL, SARL
 
SUBSTANTIALLY EQUIVALENT
 3
MEDTRONIC INC.
 
SUBSTANTIALLY EQUIVALENT
 19
MEDTRONIC SOFAMOR DANCK USA, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC SOFAMOR DANEK
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC SOFAMOR DANEK USA
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC SOFAMOR DANEK, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 22
MEDYSSEY USA, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
NEO MEDICAL S.A.
 
SUBSTANTIALLY EQUIVALENT
 1
NEUROSTRUCTURES, INC
 
SUBSTANTIALLY EQUIVALENT
 1
NEXT ORTHOSURGICAL
 
SUBSTANTIALLY EQUIVALENT
 2
NEXUS SPINE, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
NEXXT SPINE LLC
 
SUBSTANTIALLY EQUIVALENT
 1
NUVASIVE, INCORPORATED
 
SUBSTANTIALLY EQUIVALENT
 7
NVISION BIOMEDICAL TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHO DEVELOPMENT
 
SUBSTANTIALLY EQUIVALENT
 2
ORTHO DEVELOPMENT CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
ORTHOFIX
 
SUBSTANTIALLY EQUIVALENT
 5
ORTHOFIX INC.
 
SUBSTANTIALLY EQUIVALENT
 3
ORTHOFIX, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ORTHOPEDIATRICS, CORP
 
SUBSTANTIALLY EQUIVALENT
 1
PINNACLE SPINE GROUP
 
SUBSTANTIALLY EQUIVALENT
 1
PIONEER
 
SUBSTANTIALLY EQUIVALENT
 1
PIONEER SURGICAL TECHNOLOGY
 
SUBSTANTIALLY EQUIVALENT
 1
PRECISION SPINE, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
PREMIA SPINE LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
SAFE ORTHOPAEDICS
 
SUBSTANTIALLY EQUIVALENT
 5
SEASPINE ORTHOPEDICS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 6
SHANGHAI SANYOU MEDICAL CO, LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SIGNUS MEDIZINTECHNIK GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
SILONY MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
SPINAL BALANCE
 
SUBSTANTIALLY EQUIVALENT
 1
SPINAL BALANCE INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SPINAL ELEMENTS
 
SUBSTANTIALLY EQUIVALENT
 1
SPINAL ELEMENTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SPINE WAVE, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
SPINEART
 
SUBSTANTIALLY EQUIVALENT
 1
SPINECRAFT LLC
 
SUBSTANTIALLY EQUIVALENT
 2
SPINEOLOGY INC.
 
SUBSTANTIALLY EQUIVALENT
 11
SPINEOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 11
SPINESELECT, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SPINEWAY
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 4
STRYKER CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 3
SYNTHES USA PRODUCTS LLC
 
SUBSTANTIALLY EQUIVALENT
 1
WILTROM CORPORATION LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
XENCO MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
X-SPINE SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 1
X-SPINE SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
Z-MEDICAL GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Break
 1287
Adverse Event Without Identified Device Or Use Problem
 761
Fracture
 556
Loose Or Intermittent Connection
 462
Material Deformation
 368
Migration Or Expulsion Of Device
351
Device Operates Differently Than Expected
 223
Torn Material
 194
Unintended Movement
 161
Screw
 137
Detachment Of Device Or Device Component
 127
Disassembly
 110
Device Dislodged Or Dislocated
 101
Mechanical Problem
 100
Migration
 91
Device Slipped
 78
Appropriate Term/Code Not Available
 72
Detachment Of Device Component
 68
Failure To Align
 65
Insufficient Information
 55
Rod
 53
Loosening Of Implant Not Related To Bone-Ingrowth
 50
Material Split, Cut Or Torn
 49
Material Fragmentation
 47
Metal Shedding Debris
 44
Fitting Problem
 43
Material Separation
 42
Material Integrity Problem
 35
Difficult To Remove
34
Malposition Of Device
34
Calibration Problem
 29
Bent
 26
Failure To Adhere Or Bond
 22
Device Damaged By Another Device
 22
Device-Device Incompatibility
 20
Device Inoperable
 19
Mechanical Jam
 18
Naturally Worn
 18
Device Markings / Labelling Problem
 18
Disconnection
 16
Connector
 15
Compatibility Problem
 15
Material Twisted / Bent
 13
Use Of Device Problem
 13
Difficult To Insert
 12
Patient Device Interaction Problem
 12
Positioning Problem
 11
No Apparent Adverse Event
 11
Device Issue
 8
Biocompatibility
7
Failure To Disconnect
 6
Device Operational Issue
 6
Unstable
 6
Tip
 5
Noise, Audible
 5
Unstable Capture Threshold
 5
Sticking
 4
Packaging Problem
 4
Crack
 4
Dull, Blunt
 4
Misassembled
 4
Improper Or Incorrect Procedure Or Method
 4
Corroded
4
Driver
 3
Failure To Osseointegrate
 3
Peeled / Delaminated
 3
Separation Failure
3
Off-Label Use
 3
Device Handling Problem
 2
Installation-Related Problem
 2
Material Protrusion / Extrusion
 2
Device Contaminated During Manufacture Or Shipping
 2
Material Distortion
 2
Component Falling
 2
Scratched Material
 2
Difficult To Position
 2
Thread
 2
Defective Device
 2
Collapse
 2
Separation Problem
2
Fastener
 2
Device Component Or Accessory
 2
Connecting Rod
 2
Cannula
 2
Screw Head
 2
Structural Problem
 2
Device Abrasion From Instrument Or Another Object
 1
Unknown (for Use When The Device Problem Is Not Known)
 1
Component Missing
1
Failure To Calibrate
 1
No Pacing
 1
Label
 1
None
 1
Difficult Or Delayed Positioning
 1
High Impedance
 1
Unintended System Motion
 1
Output Above Specifications
 1
Device Displays Incorrect Message
1
Cap
 1
Material Disintegration
 1
Total Device Problems 6249
Recalls
Manufacturer Recall Class Date Posted
1
Alphatec Spine, Inc.
 II Jun-06-2017
2
Alphatec Spine, Inc.
 II Nov-16-2016
3
Alphatec Spine, Inc.
 II Jul-22-2014
4
Amendia, Inc
 II Jan-10-2018
5
Back 2 Basics Direct LLC
 II Aug-21-2018
6
Biomet Spine, LLC
 II Jul-20-2015
7
Biomet Spine, LLC
 II Feb-24-2015
8
Biomet Spine, LLC
 II Feb-11-2015
9
CTL Medical Corporation
 II Mar-20-2019
10
DePuy Spine, Inc.
 II May-26-2015
11
Ebi, Llc
 II Jan-05-2015
12
Genesys Orthopedics Systems, LLC
 II Sep-22-2014
13
Innovasis, Inc
 II Feb-20-2018
14
Innovasis, Inc
 II Jan-19-2016
15
Innovasis, Inc
 II Jul-16-2014
16
Integra LifeSciences Corp.
 II Aug-11-2014
17
Integra LifeSciences Corp.
 II Jul-01-2014
18
Integra LifeSciences Corp.
 II Feb-07-2014
19
Medtronic Sofamor Danek USA Inc
 II Aug-03-2018
20
OrthoPediatrics Corp
 II Jan-08-2016
21
Orthofix, Inc
 II Aug-18-2017
22
Orthofix, Inc
 II Jun-10-2015
23
PIONEER SURGICAL TECHNOLOGY, INC.
 II Sep-09-2014
24
SeaSpine Inc
 II Jun-20-2014
25
Spinal Elements, Inc
 III May-11-2015
26
Stryker Spine
 II Nov-12-2015
27
Synthes (USA) Products LLC
 I Nov-26-2014
28
Zimmer Biomet Spine Inc.
 II Feb-22-2019
29
Zimmer Spine, Inc.
 II Mar-18-2016
TPLC Last Update: 2019-04-02 20:53:21
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.