Orthosis, Cervical Pedicle Screw Spinal Fixation

Device Code: 4736

Product Code(s): NKG

Definition: This Device Is A Posterior Pedicle Screw Fixation System Indicated For Any Of The Following: Cervical Spondylolisthesis (all Grades And Types) Cervical Spondylosis Cervical Degenerative Disc Disease Degeneration Of The Cervical Facets Accompanied By

Device Classification Information

• Device Type ID: 4736
• Device Name: Orthosis, Cervical Pedicle Screw Spinal Fixation
• Physical State: Metallic Plates And Screws
• Technical Method: Uses Screws And Plates To Stabilize Spinal Segments For Fusion
• Target Area: Posterior Cervical Spine
• Review Panel: Orthopedic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Orthopedic Devices (DOD); Posterior Spine Devices Branch (PSDB)
• Submission Type: 510(k)
• FDA Device Classification: Class Unclassified Medical Device
• Product Code: NKG
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 11-296 ASTM F2193-14
  Standard Specifications And Test Methods For Components Used In The Surgical Fixation Of The Spinal Skeletal System
• 11-302 ASTM F1717-15
  Standard Test Methods For Spinal Implant Constructs In A Vertebrectomy Model
• 11-323 ASTM F2706-17
  Standard Test Methods For Occipital-Cervical And Occipital-Cervical-Thoracic Spinal Implant Constructs In A Vertebrectomy Model
• 11-332 ASTM F2193-18
  Standard Specifications And Test Methods For Components Used In The Surgical Fixation Of The Spinal Skeletal System
• 11-345 ASTM F1717-18
  Standard Test Methods For Spinal Implant Constructs In A Vertebrectomy Model
• 11-346 ASTM F2706-18
  Standard Test Methods For Occipital-Cervical And Occipital-Cervical-Thoracic Spinal Implant Constructs In A Vertebrectomy Model

Total Product Life Cycle

• Device Type ID: 4736
• Device: Orthosis, Cervical Pedicle Screw Spinal Fixation
• Product Code: NKG

Premarket Reviews
Manufacturer	Decision
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
CENTINEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS
	SUBSTANTIALLY EQUIVALENT	2
K2M
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
ORTHOFIX
	SUBSTANTIALLY EQUIVALENT	4
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	3
ORTHOFIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	3
SPINEART
	SUBSTANTIALLY EQUIVALENT	2
SPINECRAFT LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	2
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES USA PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
U & I CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULRICH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SPINE, INC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Break	95
Adverse Event Without Identified Device Or Use Problem	47
Torn Material	42
Unintended Movement	33
Migration Or Expulsion Of Device	13
Fracture	12
Detachment Of Device Or Device Component	11
Loose Or Intermittent Connection	9
Device Dislodged Or Dislocated	9
Detachment Of Device Component	7
Material Fragmentation	7
Device-Device Incompatibility	6
Device Slipped	5
Material Split, Cut Or Torn	5
Device Operates Differently Than Expected	5
Migration	5
Screw	3
Insufficient Information	3
Noise, Audible	3
Material Separation	3
Plate	2
Device Issue	1
Material Deformation	1
Physical Resistance / Sticking	1
Separation Problem	1
Mechanical Problem	1
Malposition Of Device	1
Rod	1
Component Falling	1
Disconnection	1
Appropriate Term/Code Not Available	1
Connecting Rod	1
Material Integrity Problem	1
Material Twisted / Bent	1
Total Device Problems	338

Recalls
Manufacturer		Recall Class	Date Posted
1	Orthofix, Inc	II	Apr-11-2018

TPLC Last Update: 2019-04-02 20:54:48