FDA product code · Orthopedic · Class 2
NKB: Thoracolumbosacral Pedicle Screw System
NKB is FDA's product code for "Thoracolumbosacral Pedicle Screw System": a Class 2 device classified under 21 CFR 888.3070, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for NKB
Across 342 510(k) clearances under NKB decided from 2018-01-01 to 2026-10-06, the median was 68 days from FDA receipt to decision. Half took between 44 and 141 days, and 80% were decided within 165 days. These are past clearances, not a forecast for a new submission.
| Fastest | 6 |
|---|---|
| 25th percentile | 44 |
| Median | 68 |
| 75th percentile | 141 |
| 80th percentile | 165 |
| 90th percentile | 253 |
| Slowest | 723 |
| Year | Median days | n |
|---|---|---|
| 2018 | 61 | 56 |
| 2019 | 84 | 39 |
| 2020 | 68 | 48 |
| 2021 | 61 | 32 |
| 2022 | 88 | 34 |
| 2023 | 72 | 44 |
| 2024 | 57 | 39 |
| 2025 | 61 | 24 |
| 2026 (to 10-06, partial) | 100 | 26 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
NKB in the public FDA record
| 510(k) clearances, all years | 906 |
|---|---|
| Device recalls | 181 |
| Establishment listings | 3,596 |
| GUDID device identifiers | 291,764 |
Counts of records, not of devices or events. Adverse event reports for NKB are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite NKB
16 FDA recognized consensus standards cite NKB, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F3292-19. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-369 ASTM F3292-19 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 11-375 ASTM F2193-20 — Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- 11-388 ASTM F1717-21 — Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- 11-402 ASTM F1798-21 — Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- 11-422 ASTM F1798-24 — Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-435 ASTM F3292-25 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 8-195 ASTM F2024-10 (Reapproved 2016) — Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
- 8-475 ASTM F2026-17 — Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 8-558 ASTM F3333-20 — Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 8-574 ASTM F2820-12(2021)e1 — Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
- 8-609 ASTM F2026-23 — Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
The first 15 of 16 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.