FDA product code NKB: Thoracolumbosacral Pedicle Screw System
NKB is the FDA product code for thoracolumbosacral pedicle screw system. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 908 510(k) submissions under NKB, 165 in the last five years, from 278 different applicants. The average 510(k) review took 101 days (median 76); 105 days on average over the last three years. FDA has posted 182 recalls for NKB devices, 21 initiated in the last five years.
Definition
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Classification
| Field | Value |
|---|---|
| Device name | Thoracolumbosacral Pedicle Screw System |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NKB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 63 | 79 |
| 2018 | 56 | 96 |
| 2019 | 39 | 116 |
| 2020 | 48 | 109 |
| 2021 | 32 | 109 |
| 2022 | 34 | 147 |
| 2023 | 44 | 114 |
| 2024 | 39 | 103 |
| 2025 | 24 | 84 |
| 2026 | 24 | 128 |
Compare with all 510(k) review times · Search every NKB clearance
Top NKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 46 | 2026-04-21 |
| Medtronic Sofamor Danek | 36 | 2017-05-11 |
| Depuy Spine, Inc. | 30 | 2014-11-19 |
| Globus Medical, Inc. | 24 | 2026-05-07 |
| Stryker Spine | 22 | 2023-06-08 |
273 more applicants have NKB clearances. See the full list in Caduvo.
Most recent NKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262091 | Ortler Global Tibbi Gerecler Anonim Sirketi | FRAXION Spinal Fixation System | 2026-09-17 | 87 |
| K262193 | Xenix Medical | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | 2026-09-14 | 77 |
| K262828 | S.M.A.I.O | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026-09-04 | 25 |
| K253943 | Zavation Medical Products, LLC | Tiger 2 System | 2026-07-24 | 226 |
| K260362 | MANTIZ Co., Ltd. | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | 2026-07-24 | 170 |
Recalls for NKB devices
182 product recalls in 86 recall events; 21 initiated in the last five years and 17 still open. Most recent: 2026-08-19.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 5 |
| 2019 | 4 |
| 2020 | 33 |
| 2021 | 1 |
| 2022 | 7 |
| 2023 | 2 |
| 2024 | 6 |
| 2025 | 3 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code NKB?
NKB is the FDA product code for thoracolumbosacral pedicle screw system. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is NKB?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code NKB?
Across 908 cleared submissions the average was 101 days from receipt to decision (median 76).
Which companies have the most NKB clearances?
Medtronic Sofamor Danek USA, Inc. (46); Medtronic Sofamor Danek (36); Depuy Spine, Inc. (30); Globus Medical, Inc. (24); Stryker Spine (22).
Have NKB devices been recalled?
Yes: 182 product recalls across 86 recall events; the most recent began 2026-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code NKB
- Run a recall and safety report across every NKB manufacturer
- Watch product code NKB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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