510(k) Report

FDA applicant

Wiltrom Corporation Limited

Zhubei City, TW5 decisions2012–20200 recalls

FDA records 5 decisions for Wiltrom Corporation Limited (Zhubei City, TW) from 2012 to 2020: 5 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 167 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 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 Wiltrom Corporation Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12018: 32020: 1
2012high 3 (2018) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Wiltrom Corporation Limited by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wiltrom Corporation Limited’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 Compound3decisions
  • NKBThoracolumbosacral Pedicle Screw System2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 167 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K110949Bicera (TM) Resorbable Bone SubstituteWiltrom Corporation Limited · 20122cite it
  • K172548Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 20181cites it

What has FDA decided for it lately?

  • K202894Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2020
  • K180758Osteocera Resorbable Bone SubstituteWiltrom Corporation Limited · 2018
  • K172237Bicera Resorbable Bone SubstituteWiltrom Corporation Limited · 2018
  • K172548Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2018
  • K110949Bicera (TM) Resorbable Bone SubstituteWiltrom Corporation Limited · 2012

All 5 as Wiltrom Corporation Limited →