# Sterigenics US LLC (contract sterilizer, Fort Worth, TX): 58 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Sterigenics US LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Fort Worth, TX, US |
| New listings | 58 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Thoracolumbosacral Pedicle Screw System; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical; Spinal Vertebral Body Replacement Device; Mallet; Rongeur, Manual |
| Product codes | MAX, NKB, HSN, KDI, OVD, ODP, OVE, MQP, HXL, HAE, HRX, KWS, PHX, KSR, JDR |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, Gastroenterology, Urology, General, Plastic Surgery, Neurology, Hematology, General Hospital |
| Brand names | Tera-P; Janus HA Coated Fenestrated Screw; Salto Talaris Total Ankle Prosthesis; XT Revision Ankle Replacement System; Pillar SA Implant System; PTC Pillar SA Spacer Implant System; FORZA Titanium Spacer Implant System; Construx Mini Spacer Implant Spaces PEEK |
| First new listing | 2026-05-26 |
| Latest new listing | 2026-08-19 |
| FDA registration number | 1649518 |
| 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.