510(k) Report

FDA applicant

Otis Biotech Co., Ltd.

Siheung-Si, Gyounggi-Do, KR3 decisions2009–20170 recalls

FDA records 3 decisions for Otis Biotech Co., Ltd. (Siheung-Si, Gyounggi-Do, KR) from 2009 to 2017: 3 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and LZO (Prosthesis, Hip, Semi-Constrained…). Its devices cite 19 predicates, 0 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 Otis Biotech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 12011: 12017: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Otis Biotech Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Otis Biotech 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?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…1decision
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision

Whose devices does it build on?

Its devices cite 19 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd. · 20172cite it

What has FDA decided for it lately?

  • K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd. · 2017
  • K101472Multifit Total Hip SystemOtis Biotech Co., Ltd. · 2011
  • K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd. · 2009

All 3 as Otis Biotech Co., Ltd. →