# Isomedix Operations, Inc. (contract sterilizer, Libertyville, IL): 99 new FDA device listings, incl. orthopedic stereotaxic instrument

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Isomedix Operations, Inc. |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Libertyville, IL, US |
| New listings | 99 |
| Devices | Orthopedic Stereotaxic Instrument; Intervertebral Fusion Device With Integrated Fixation, Cervical; Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Hemostatic Wound Dressing Without Thrombin Or Other Biologics; Starter, Bone Screw; Air-Handling Apparatus Accessory |
| Product codes | OLO, OVE, MQV, HRS, KWD, KWS, PHX, QSY, HWD, QGI, NKB, HWC, KTT, QKL, OUR |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Neurology, Orthopedic, General, Plastic Surgery, General Hospital |
| Brand names | Millstone4075 (LN) - Velys Robotic-Assisted Solution; Cresilon7733 (WH, LN*) - TRAUMAGEL; TRAUMAGEL Hemostatic Gel; Healeon9978 (LN) - Puregraft SYNC; Hyalex8046 (NR,LN*) - HYALEX Slalom MTP Hemiarthroplasty Implant; Cresilon7733 (WH,LN*) - TRAUMAGEL; TRAUMAGEL Hemostatic Gel; Zimmer (LN) - OSSTM Orthopedic Salvage System |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-10-21 |
| FDA registration number | 1450662 |
| Registration expires | 2027-12-31 |

## 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.
- Listed in the last 45 days.

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: 2026-11-04T21:52:36.524Z.
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.