FDA product code · Orthopedic · Class 2
OUR: Sacroiliac Joint Fixation
OUR is FDA's product code for "Sacroiliac Joint Fixation": a Class 2 device classified under 21 CFR 888.3040, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for OUR
Across 98 510(k) clearances under OUR decided from 2018-01-01 to 2026-10-06, the median was 88 days from FDA receipt to decision. Half took between 31 and 148 days, and 80% were decided within 177 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 31 |
| Median | 88 |
| 75th percentile | 148 |
| 80th percentile | 177 |
| 90th percentile | 245 |
| Slowest | 641 |
| Year | Median days | n |
|---|---|---|
| 2018 | 82 | 7 |
| 2019 | 89 | 7 |
| 2020 | 88 | 7 |
| 2021 | 85 | 9 |
| 2022 | 149 | 14 |
| 2023 | 55 | 20 |
| 2024 | 74 | 15 |
| 2025 | 97 | 14 |
| 2026 (to 10-06, partial) | 110 | 5 |
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.
OUR in the public FDA record
| 510(k) clearances, all years | 132 |
|---|---|
| Establishment listings | 333 |
| GUDID device identifiers | 7,424 |
Counts of records, not of devices or events. Adverse event reports for OUR 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 OUR
9 FDA recognized consensus standards cite OUR, among them ASTM F3574-22; ASTM F3574-25; ISO 5834-3 Second edition 2019-02. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-398 ASTM F3574-22 — Standard Test Methods for Sacroiliac Joint Fusion Devices
- 11-446 ASTM F3574-25 — Standard Test Methods for Sacroiliac Joint Fusion Devices
- 8-495 ISO 5834-3 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
- 8-496 ISO 5834-4 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
- 8-497 ISO 5834-5 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
- 8-501 ISO 5834-1 Fourth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
- 8-514 ISO 5834-2 Fifth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
- 8-572 ASTM F2565-21 — Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- 8-573 ASTM F2695-12(2025) — Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.