# Dot America, Inc. (contract manufacturer, Columbia City, IN): 5 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Dot America, Inc. |
| Owner / operator | DOT America, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Columbia City, IN, US |
| New listings | 5 |
| Devices | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Product codes | KWZ, LWJ, KWY, MEH, LZO |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Z1 |
| First new listing | 2026-08-05 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 3011461101 |
| 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.

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.