# Synergy Health Westport Ltd (contract sterilizer, Westport Mayo, IE): 13 new FDA device listings, incl. hydrogel spacer

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Synergy Health Westport Ltd |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Westport Mayo, IE |
| New listings | 13 |
| Devices | Hydrogel Spacer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Catheter, Peripheral, Atherectomy; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Screw, Fixation, Bone; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Product codes | OVB, MBH, OIY, JWH, MCW, MEH, LZO, HWC, LPH, KWZ, MAY, MBL, QFC |
| Device classes | Class II |
| Medical specialties | Radiology, Orthopedic, Cardiovascular, General, Plastic Surgery |
| Brand names | Zimmer (DK,WP) - Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) |
| First new listing | 2026-07-20 |
| Latest new listing | 2026-10-14 |
| FDA registration number | 3010173425 |
| 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.
- 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.
