# Zimmer, Inc. (contract manufacturer, Warsaw, IN): 28 new FDA device listings, incl. screw, fixation, bone

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Zimmer, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device |
| Location | Warsaw, IN, US |
| New listings | 28 |
| Devices | Screw, Fixation, Bone; Plate, Fixation, Bone; Washer, Bolt Nut; Cerclage, Fixation; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Stimulator, Nerve |
| Product codes | HWC, HRS, HTN, JDQ, KTT, KWS, PHX, KWT, PKC, ETN, GXH, OQI, OQH, JDI, LZO |
| Device classes | Class II |
| Medical specialties | Orthopedic, Ear, Nose, Throat, Neurology |
| Brand names | Cable-Ready Cable Grip System; Augment Off-Axis Instrument System; OsseoFit Stemless Shoulder System; Iovera System; Iovera Smart Tip, Stimulating (1X90MM), 5-Pack; G7 Acetabular System; Iovera Smart Tip (3X8.5MM), 5-Pack; Iovera Smart Tip (1X90MM), 5-Pack |
| First new listing | 2026-06-03 |
| Latest new listing | 2026-09-29 |
| FDA registration number | 1822565 |
| 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.