FDA Product Code NKB: Thoracolumbosacral Pedicle Screw System
FDA product code NKB covers thoracolumbosacral pedicle screw systems.
These spinal implants are designed to provide immobilization and stabilization of the thoracic, lumbar, and sacral spine. Pedicle screws are inserted into the vertebral pedicles and connected via rods to correct deformity, treat fractures, or facilitate fusion.
NKB devices are Class II medical devices, regulated under 21 CFR 888.3070 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medtronic Sofamor Danek USA, Inc., Medtronic Sofamor Danek and Depuy Spine, Inc..
905
Total
905
Cleared
101d
Avg days
2003
Since
Declining activity -
61 submissions in the last 2 years
vs 83 in the prior period
Review times increasing: avg
118d
recently vs 100d historically
FDA 510(k) Cleared Thoracolumbosacral Pedicle Screw System Devices (Product Code NKB)
905 devices
Cleared
Jul 14, 2026
Invictus® Small Stature Spinal Fixation System
Alphatec Spine, Inc.
Orthopedic
88d
Cleared
May 15, 2026
Varion Thoracolumbar Fixation System
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic
51d
Cleared
May 07, 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
Globus Medical, Inc.
Orthopedic
164d
Cleared
May 05, 2026
AccelFix Spinal Fixation System
L & K Biomed Co., Ltd.
Orthopedic
29d
Cleared
May 01, 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
Spineart SA
Orthopedic
141d
Cleared
Apr 29, 2026
LEO Spinal System
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
260d
Cleared
Apr 28, 2026
M.U.S.T. Pedicle Screw System - Extension
Medacta International S.A.
Orthopedic
140d
Cleared
Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
Medtronic Sofamor Danek USA, Inc.
Orthopedic
88d
Cleared
Apr 16, 2026
ARx® SAI Implant System
Life Spine, Inc.
Orthopedic
107d
Cleared
Apr 03, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
Orthopedic
24d
Cleared
Feb 24, 2026
OSTEOMNI SPINAL FIXATION SYSTEM
OSTEOMNI, Inc.
Orthopedic
57d
Cleared
Feb 23, 2026
Duet™ Spinal Fixation System
Box Spine, LLC
Orthopedic
150d
Cleared
Feb 10, 2026
Vulcan Spinal System
K2m, Inc.
Orthopedic
88d
Cleared
Jan 13, 2026
Swedge™ Pedicle Screw Fixation System Bezier Rod
Spinal Resources, Inc.
Orthopedic
161d
Cleared
Jan 07, 2026
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
Medtronic Sofamor Danek USA, Inc.
Orthopedic
29d
Cleared
Jan 07, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
Orthopedic
26d
Cleared
Dec 17, 2025
Vital™ Spinal Fixation System
Highridge Medical, LLC
Orthopedic
85d
Cleared
Dec 17, 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
Orthopedic
23d
Cleared
Nov 18, 2025
Universal Spinal System
Double Medical Technology, Inc.
Orthopedic
82d
Cleared
Oct 24, 2025
Fule Spinal Fixation System
Beijing Fule Science & Technology Development Co., Ltd.
Orthopedic
57d
Cleared
Oct 24, 2025
CD Horizon™ Spinal System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
24d
Cleared
Oct 21, 2025
OLYMPIC Posterior Spinal Fixation System
Astura Medical
Orthopedic
85d
Cleared
Oct 21, 2025
TriALTIS™ Spine System
Medos International SARL
Orthopedic
22d
Cleared
Oct 20, 2025
A8 INTEGR8™ Porous Pedicle Screws
Allumin8, Inc.
Orthopedic
397d
About Product Code NKB - Regulatory Context
510(k) Submission Activity
905 total 510(k) submissions under product code NKB since 2003, with 905 receiving FDA clearance (average review time: 101 days).
Submission volume has declined in recent years - 61 submissions in the last 24 months compared to 83 in the prior period.
FDA 510(k) Review Time - NKB Product Code
Recent submissions under NKB have taken an average of 118 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.
NKB devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →