510(k) Report

FDA applicant

Tianjin Zhengtian Medical Instrument Co., Ltd.

Tianjin, CN3 decisions2016–20180 recalls

FDA records 3 decisions for Tianjin Zhengtian Medical Instrument Co., Ltd. (Tianjin, CN) from 2016 to 2018: 3 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 266 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Tianjin Zhengtian Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12017: 12018: 1
2016high 1 (2016) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Tianjin Zhengtian Medical Instrument Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone1decision
  • HRSPlate, Fixation, Bone1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 266 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 109 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K172267IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2018
  • K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2017
  • K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2016

All 3 as Tianjin Zhengtian Medical Instrument Co., Ltd. →