FDA product code NKG: Posterior Cervical Screw System
NKG is the FDA product code for posterior cervical screw system. It is a Class II device, regulated under 21 CFR 888.3075 and reviewed by the Orthopedic panel. FDA has cleared 119 510(k) submissions under NKG, 30 in the last five years, from 63 different applicants. The average 510(k) review took 98 days (median 71); 132 days on average over the last three years. FDA has posted 6 recalls for NKG devices.
Definition
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Classification
| Field | Value |
|---|---|
| Device name | Posterior Cervical Screw System |
| Device class | Class II |
| Regulation | 21 CFR 888.3075 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NKG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 15 | 126 |
| 2018 | 12 | 75 |
| 2019 | 8 | 57 |
| 2020 | 14 | 90 |
| 2021 | 7 | 68 |
| 2022 | 7 | 124 |
| 2023 | 10 | 89 |
| 2024 | 3 | 151 |
| 2025 | 6 | 87 |
| 2026 | 4 | 158 |
Compare with all 510(k) review times · Search every NKG clearance
Top NKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 7 | 2026-01-21 |
| Orthofix, Inc. | 7 | 2021-07-30 |
| Medos International SARL | 6 | 2023-11-09 |
| Nu Vasive, Incorporated | 6 | 2022-09-09 |
| Medacta International S.A. | 6 | 2022-04-26 |
58 more applicants have NKG clearances. See the full list in Caduvo.
Most recent NKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254260 | GS Medical Co., Ltd. | The VEGA Cervical Screw System | 2026-09-17 | 262 |
| K253195 | ZheJiang Decans Medical Devices Co., Ltd. | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | 2026-06-02 | 249 |
| K254045 | CarboFix Orthopedics , Ltd. | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | 2026-03-16 | 89 |
| K254165 | Medtronic Sofamor Danek USA, Inc. | Infinity OCT System | 2026-01-21 | 30 |
| K252327 | Icotec AG | CMORE® CT System; CMORE® CT System Navigated Instruments | 2025-11-12 | 110 |
Recalls for NKG devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-12-14.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code NKG?
NKG is the FDA product code for posterior cervical screw system. It is a Class II device, regulated under 21 CFR 888.3075 and reviewed by the Orthopedic panel.
What device class is NKG?
Class II, regulation 21 CFR 888.3075. Typical premarket route: 510(k).
How long does a 510(k) take for product code NKG?
Across 119 cleared submissions the average was 98 days from receipt to decision (median 71).
Which companies have the most NKG clearances?
Medtronic Sofamor Danek USA, Inc. (7); Orthofix, Inc. (7); Medos International SARL (6); Nu Vasive, Incorporated (6); Medacta International S.A. (6).
Have NKG devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2020-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code NKG
- Run a recall and safety report across every NKG manufacturer
- Watch product code NKG 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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