510(k) Report

FDA applicant

B-One Ortho, Corp.

Cedar Knolls, NJ13 decisions2018–20260 recalls

FDA records 13 decisions for B-One Ortho, Corp. (Cedar Knolls, NJ) from 2018 to 2026: 13 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LZO (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 75 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 6 of them its own earlier devices. No 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 B-One Ortho, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 22019: 22020: 12021: 32022: 22024: 12026 (partial year): 2
2018high 3 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — B-One Ortho, Corp. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like B-One Ortho, Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…4decisions
  • MAIFastener, Fixation, Biodegradable, Soft Tissue1decision
  • KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 75 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 100 days; 3 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 6 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202429Mobio Total Knee SystemB-One Ortho, Corp. · 20202cite it
  • K222431b-ONER MOBIO Total Knee SystemB-One Ortho, Corp. · 20221cites it
  • K180446b-ONE Total Knee SystemB-One Ortho, Corp. · 20181cites it
  • K202768KOSMO Femoral StemB-One Ortho, Corp. · 20211cites it
  • K210483MOBIO Total Knee SystemB-One Ortho, Corp. · 20211cites it

What has FDA decided for it lately?

  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K253357b-ONE® Bipolar HeadB-One Ortho, Corp. · 2026
  • K240528b-ONE® Total Hip SystemB-One Ortho, Corp. · 2024
  • K222431b-ONER MOBIO Total Knee SystemB-One Ortho, Corp. · 2022
  • K213673b-ONE MOBIO Total Knee SystemB-One Ortho, Corp. · 2022
  • K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix…B-One Ortho, Corp. · 2021
  • K210483MOBIO Total Knee SystemB-One Ortho, Corp. · 2021
  • K202768KOSMO Femoral StemB-One Ortho, Corp. · 2021

All 13 as B-One Ortho, Corp. →