# Synergy Health Sterilisation UK Ltd (contract sterilizer, Berkshire Reading, GB): 29 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, cemented

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Synergy Health Sterilisation UK Ltd |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Berkshire Reading, GB |
| New listings | 29 |
| Devices | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Product codes | JDI, LZO, KWY, MEH, KWL, LPH, MBH, JWH, OIY, KWZ, DZL, JEY, FRO, LZY |
| Device classes | Class II, Unclassified |
| Medical specialties | Orthopedic, Dental |
| Brand names | PolarSeal (RG,DV*) - Acutarex PDR 60 Healing System |
| First new listing | 2026-09-30 |
| Latest new listing | 2026-10-19 |
| FDA registration number | 3002807310 |
| 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: 2026-11-04T21:52:36.524Z.
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.