# Isomedix Operations, Inc. (contract sterilizer, Libertyville, IL): 124 new FDA device listings, incl. starter, bone screw

**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 | 124 |
| Devices | Starter, Bone Screw; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Ankle, Uncemented, Non-Constrained; Fastener, Fixation, Nondegradable, Soft Tissue; Hemostatic Wound Dressing Without Thrombin Or Other Biologics; Plate, Fixation, Bone; Screw, Fixation, Bone; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Filler, Bone Void, Calcium Compound |
| Product codes | HWD, HSN, NTG, MBI, QSY, HRS, HWC, KWS, PHX, MQV, PAO, MBF, KWZ, KTT, KWI |
| Device classes | Class I, Class II, Class III, Unclassified |
| Medical specialties | Orthopedic, General, Plastic Surgery, Neurology, General Hospital, Gastroenterology, Urology |
| Brand names | Zimmer (LN) - PMI® Custom Device; Cresilon7733 (WH,LN*) - TRAUMAGEL; TRAUMAGEL Hemostatic Gel; Cresilon7733 (WH, LN*) - TRAUMAGEL; TRAUMAGEL Hemostatic Gel; Healeon9978 (LN) - Puregraft SYNC; Hyalex8046 (NR,LN*) - HYALEX Slalom MTP Hemiarthroplasty Implant; Zimmer (LN) - OSSTM Orthopedic Salvage System |
| First new listing | 2026-05-04 |
| Latest new listing | 2026-10-14 |
| 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: 2026-10-28T20:51:27.468Z.
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.