# Sterigenics U.S., LLC (contract sterilizer, Atlanta, GA): 10 new FDA device listings, incl. prosthesis, ankle, semi-constrained, cemented, metal/polymer

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Sterigenics U.S., LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Atlanta, GA, US |
| New listings | 10 |
| Devices | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Toe, Constrained, Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Arthroscope |
| Product codes | HSN, KWH, MBI, HRX |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Cadence Total Ankle System; Silicone Toe System - CGT; Morphix XT; 8.4MM/50MM CANNULA 10 EA; 8.4MM/75MM CANNULA 10 EA; 6MM/75MM CANNULA 10 EA; TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR WITH TWO NO.2 (5 METRIC) HI-FI SUTURE WITH NEEDLES; TRUSHOT WITH Y-KNOT 1.3MM ALL-SUTURE ANCHOR WITH ONE NO.2 (5 METRIC) HI-FI SUTURE WITH NEEDLES |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 1018470 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.