510(k) Report

FDA applicant

Orthorebirth Co., Ltd.

Yokohama, JP4 decisions2014–20242 recalls

FDA records 4 decisions for Orthorebirth Co., Ltd. (Yokohama, JP) from 2014 to 2024: 4 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Since 2016 its 510(k)s took a median of 109 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. 2 recalls are 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 Orthorebirth Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014: 12017: 22024: 1
2014high 2 (2017) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2026

2026 (partial year): 2
2014high 2 (2026) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Orthorebirth Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthorebirth Co., Ltd.’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?

  • MQVFiller, Bone Void, Calcium Compound4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 109 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 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.

  • K172573ReBOSSIS85Orthorebirth Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K240453ReBOSSISOrthorebirth Co., Ltd. · 20242 recalls
  • K172573ReBOSSIS85Orthorebirth Co., Ltd. · 20172 recalls
  • K170620ReBOSSIS85Orthorebirth Co., Ltd. · 20172 recalls
  • K142090RebossisOrthorebirth Co., Ltd. · 2014

All 4 as Orthorebirth Co., Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K240453Zenbone, Ref: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C-ZMar 25, 2026Class II
  • K240453BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC…Mar 25, 2026Class II