# RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (K262193): 510(k) cleared for Xenix Medical

**Predicate Speed & CAPA Advisory Opportunity Score:** 30/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262193 |
| Device | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology |
| Applicant | Xenix Medical |
| Specialty / panel | Orthopedic |
| Product code | NKB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-29 |
| Decision date | 2026-09-14 |
| Review time (days) | 77 |
| Third-party review | No |
| Applicant location | Orlando, FL, US |

## Why this score
- Fast 77-day review: this device is a strong predicate for similar products.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262193). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.