# Howmedica Osteonics Corp (manufacturer, Mahwah, NJ): 11 new FDA device listings, incl. cement obturator

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Howmedica Osteonics Corp |
| Owner / operator | Stryker Corp. |
| Role | Manufacturer |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Mahwah, NJ, US |
| New listings | 11 |
| Devices | Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Product codes | LZN, LZO, LPH, JDI, MEH, KWL, LWJ, KWZ, MBH, JWH, KRO |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic |
| Brand names | Constrained Acetabular Insert; Trident Crossfire 0 deg Polyethylene Insert; Trident Crossfire 10 deg Poly Insert; System 12 Crossfire 10 deg Insert; Trident All Poly Constrained Acetabular Insert; Crossfire Eccentric Insert 10 deg; Trident 0 deg Constrained Acetabular Insert; Trident Constrained Acetabular Liner; Omnifit 20 degree Series I insert; Omnifit Crossfire 10 deg Series II Insert; Artisan Bone Plug; UHR Bipolar Component; Scorpio Flex CR and PS Tibial Insert; Scorpio NRG CR and PS Tibial Insert; Triathlon All Poly Tibial Component - CR and PS |
| First new listing | 2026-07-17 |
| Latest new listing | 2026-08-12 |
| FDA registration number | 2249697 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

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.