Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of OrthosoftLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orthosoft Inc. (d/b/a) Zimmer CAS with 6 510(k) clearances and 1 AI-enabled device. The most recent is a 510(k) clearance dated Jun 4, 2026: Signature™ ONE System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 4, 2026 | Signature™ ONE SystemK261510 · QHE | 510(k) clearances |
| May 21, 2026 | ROSA® Shoulder SystemK260582 · OLO | 510(k) clearances |
| Feb 4, 2026 | Signature™ ONE SystemK260104 · QHE | 510(k) clearances |
| Feb 4, 2026 | Signature ONE SystemK260104 · Orthopedic | AI-enabled devices |
| Nov 13, 2025 | Rosa® Knee SystemK251314 · OLO | 510(k) clearances |
| Oct 18, 2024 | ROSA® Knee SystemK242864 · OLO | 510(k) clearances |
| Dec 12, 2023 | Signature™ ONE SystemK232425 · QHE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
