510(k) Report

FDA applicant

Tianjin Walkman Biomaterial Co., Ltd.

Shanghai, CN3 decisions2013–20140 recalls

FDA records 3 decisions for Tianjin Walkman Biomaterial Co., Ltd. (Shanghai, CN) from 2013 to 2014: 3 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 5 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 Walkman Biomaterial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2013: 12014: 2
2013high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Tianjin Walkman Biomaterial Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tianjin Walkman Biomaterial 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?

  • HRSPlate, Fixation, Bone1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • HSBRod, Fixation, Intramedullary And Accessories1decision

Whose devices does it build on?

Its devices cite 5 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.

  • K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 20131cites it
  • K132078Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd. · 20141cites it

What has FDA decided for it lately?

  • K140229General Spinal SystemTianjin Walkman Biomaterial Co., Ltd. · 2014
  • K132078Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd. · 2014
  • K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 2013

All 3 as Tianjin Walkman Biomaterial Co., Ltd. →