510(k) Report

FDA applicant

Orthosoft Inc (D/B/A Zimmer Cas)

Montreal, CA27 decisions2017–20260 recalls

FDA records 27 decisions for Orthosoft Inc (D/B/A Zimmer Cas) (Montreal, CA) from 2017 to 2026: 27 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and QHE (Shoulder Arthroplasty Implantation System). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 23 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Orthosoft D/B/A Zimmer Cas”, “Orthosoft Inc. (d/b/a) Zimmer CAS”, “Orthosoft Inc. (D/B/A) Zimmer Cas)”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Orthosoft Inc (D/B/A Zimmer Cas)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12019: 52020: 12021: 42022: 42023: 62024: 22025: 12026 (partial year): 3
2017high 6 (2023) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Orthosoft Inc (D/B/A Zimmer Cas) by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthosoft Inc (D/B/A Zimmer Cas)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument13decisions
  • QHEShoulder Arthroplasty Implantation System6decisions
  • LLZSystem, Image Processing, Radiological4decisions
  • SBFOrthopedic Augmented Reality2decisions
  • KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1decision
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision

How long do its 510(k) reviews take?

Since 2016, its 25 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 12 of its 25 were faster than that.

Whose devices does it build on?

Its devices cite 36 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 23 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 20198cite it
  • K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 20193cite it
  • K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 20242cite it
  • K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 20222cite it
  • K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 20232cite it
  • K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 20212cite it

What has FDA decided for it lately?

  • K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
  • K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
  • K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
  • K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2025
  • K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2024
  • K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
  • K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023
  • K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas · 2023

All 14 as Orthosoft Inc (D/B/A Zimmer Cas) →All 7 as Orthosoft D/B/A Zimmer Cas →All 5 as Orthosoft Inc. (d/b/a) Zimmer CAS →

Other applicant names beginning “Orthosoft”

FDA records each applicant name separately; these may or may not be the same firm.

Orthosoft, Inc. 14