FDA product code · Orthopedic
NKBThoracolumbosacral Pedicle Screw System
Product code NKB covers Thoracolumbosacral Pedicle Screw System, a Class II device regulated under 21 CFR 888.3070. FDA has cleared 905 devices in this code, 31 of them in the last 12 months. Median review time across the 905 most recent decisions is 76 days. openFDA lists 181 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3070
- Review panel
- Orthopedic
- Clearances
- 905
What is happening in NKB right now?
NKB (Thoracolumbosacral Pedicle Screw System) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2762-2026, Z-2859-2026, Z-0478-2026). 11 first-time filers in the last 12 months, including MANTIZ Co., Ltd. and Socko Medical Co., Ltd (K260362, K253045, K251251, K260989, K252542). The code is crowded, scoring 100 of 100 — 240 companies hold a clearance here and 31 arrived in the last 12 months (NKB:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2762-2026, Z-2859-2026, Z-0478-2026 |
| New entrant | Worth knowing | K260362, K253045, K251251, K260989, K252542 |
| Crowding | Context | NKB:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code NKB cover?
NKB is FDA's product code for Thoracolumbosacral Pedicle Screw System, a Class II device regulated under 21 CFR 888.3070.
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Source: openFDA device/classification · record NKB · retrieved
How many devices has FDA cleared in NKB?
FDA has cleared 905 devices under product code NKB since the 510(k) programme began in 1976, 31 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | |
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | |
| K253045 | Socko Vimax Spinal Fixation System | Socko Medical Co., Ltd. | |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | |
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | Globus Medical, Inc. | |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA |
How long does FDA review take for NKB?
The median FDA review time for NKB is 76 days, measured across the 905 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in NKB?
openFDA lists 181 recall records against product code NKB. A recall record covers one firm's corrective action and may span many device lots.
Z-2762-2026Open, ClassifiedSEASPINE ORTHOPEDICS CORPORATION
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Z-2859-2026Open, ClassifiedInnovasis, Inc
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.
Z-0478-2026Open, ClassifiedOrthofix U.S. LLC
Polyaxial screws do not meet performance standards.
Z-2279-2025Open, ClassifiedSPINEART SA
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Z-2280-2025Open, ClassifiedSPINEART SA
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Showing the 5 most recently initiated of 181. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for NKB?
MAUDE holds 3,730 adverse-event reports naming product code NKB, 816 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in NKB unusual?
Every month with enough history behind it falls inside NKB's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 43 | Insufficient history | No expected range — too little history | |
| 53 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 67 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 79 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 73 | Insufficient history | No expected range — too little history | |
| 126 | Insufficient history | No expected range — too little history | |
| 360 | Insufficient history | No expected range — too little history | |
| 64 | Insufficient history | No expected range — too little history | |
| 92 | Insufficient history | No expected range — too little history | |
| 109 | Insufficient history | No expected range — too little history | |
| 153 | Insufficient history | No expected range — too little history | |
| 93 | Insufficient history | No expected range — too little history | |
| 105 | Insufficient history | No expected range — too little history | |
| 127 | Insufficient history | No expected range — too little history | |
| 173 | Insufficient history | No expected range — too little history | |
| 97 | Insufficient history | No expected range — too little history | |
| 114 | Insufficient history | No expected range — too little history | |
| 119 | Insufficient history | No expected range — too little history | |
| 84 | 0–262 | Within expected (0–262) | |
| 100 | 41–134 | Within expected (41–134) | |
| 95 | 57–148 | Within expected (57–148) | |
| 101 | 58–150 | Within expected (58–150) | |
| 122 | 54–140 | Within expected (54–140) | |
| 76 | 66–149 | Within expected (66–149) | |
| 53 | 84–225 | Below expected (84–225) | |
| 63 | 23–165 | Within expected (23–165) | |
| 99 | 9–171 | Within expected (9–171) | |
| 103 | 27–154 | Within expected (27–154) | |
| 133 | 28–143 | Within expected (28–143) | |
| 114 | 44–177 | Within expected (44–177) | |
| 96 | 53–204 | Within expected (53–204) | |
| 121 | 35–166 | Within expected (35–166) | |
| 99 | 47–186 | Within expected (47–186) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in NKB.
Who has entered NKB in the last year?
8 companies filed in NKB for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| MANTIZ Co., Ltd. | K260362 | |
| Socko Medical Co., Ltd. | K253045 | |
| Chanpin Medtak Co., Ltd. | K251251 | |
| Kyocera Medical Technologies Inc. (KMTI) | K260989 | |
| ZheJiang Decans Medical Devices Co., Ltd. | K252542 | |
| Osteomni, Inc. | K254247 | |
| Box Spine, LLC | K253169 | |
| Highridge Medical, LLC | K253093 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in NKB?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in NKB?
Across the 905 most recent decisions, these applicants filed most often in NKB.
| Applicant | Recent clearances |
|---|---|
| Medtronic Sofamor Danek USA, Inc. | 46 |
| Medtronic Sofamor Danek | 36 |
| Depuy Spine, Inc. | 30 |
| Globus Medical, Inc. | 24 |
| Stryker Spine | 22 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in NKB file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Medtronic Sofamor Danek, Inc. | 50 | 2 |
| Medtronic Sofamor Danek USA, Inc | 48 | 2 |
| Life Spine, Inc. | 22 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch NKB
Get an email the morning anything changes in NKB — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.