510(k) Report

FDA applicant

Nextstep Arthropedix

Akron, OH2 decisions2024–20251 recall

FDA records 2 decisions for Nextstep Arthropedix (Akron, OH) from 2024 to 2025: 2 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and MEH (Prosthesis, Hip, Semi-Constrained, Uncemented…). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

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

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

How often FDA has decided Nextstep Arthropedix’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2024high 1 (2025) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Nextstep Arthropedix by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision
  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix · 20241cites it

What has FDA decided for it lately?

  • K242410NextStep Arthropedix Total Knee SystemNextstep Arthropedix · 2025
  • K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix · 20241 recall

All 2 as Nextstep Arthropedix →

What has been recalled?

1 recall linked to its devices; the latest:

  • K191297iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar…Sep 11, 2025Class II

Other applicant names beginning “Nextstep”

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

Nextstep Arthopedix, LLC 1