510(k) Report

FDA applicant

Rootloc Co., Ltd.

Geumcheon-Gu, KR2 decisions2018–20180 recalls

FDA records 2 decisions for Rootloc Co., Ltd. (Geumcheon-Gu, KR) in 2018: 2 510(k) clearances. All are in product code JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 6 predicates, 1 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 Rootloc Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2018: 2
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Rootloc Co., Ltd. by year, 2018–2026Sources: 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/Polymer2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K170753Acculoc Total Knee SystemRootloc Co., Ltd. · 20183cite it

What has FDA decided for it lately?

  • K182370Acculoc Total Knee SystemRootloc Co., Ltd. · 2018
  • K170753Acculoc Total Knee SystemRootloc Co., Ltd. · 2018

All 2 as Rootloc Co., Ltd. →