# Isomedix Operations Inc. (contract sterilizer, Whippany, NJ): 26 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); Manufacture Device in the United States for Export Only |
| Location | Whippany, NJ, US |
| New listings | 26 |
| Devices | Orthopedic Stereotaxic Instrument; Wax, Bone; Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside; Methyl Methacrylate For Cranioplasty; Filler, Bone Void, Calcium Compound; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Dura Substitute; Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Product codes | OLO, MTJ, QRR, GXP, MQV, OIS, GXQ, QSY |
| Device classes | Class II, Unclassified |
| Medical specialties | Neurology, Orthopedic |
| Brand names | Zimmer (WH) - ROSA Partial Knee System; Zimmer (WH) - CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150; Abyrx4508 (WH) - Permatage XT Settable Bone Putty; Lifenet2559 (CH1,WH*) - ReadiGraft T; Lifenet2559 (CH1,WH*) - PliaFX Pak V; Lifenet2559 (CH1,WH*) - PliaFX Pak T; Lifenet2559 (CH1,WH*) - ReadiGraft V; Abyrx4508 (WH) - Permatage Flowable Settable Bone Paste |
| First new listing | 2026-06-23 |
| Latest new listing | 2026-09-28 |
| FDA registration number | 2245304 |
| 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.