510(k) Report

FDA applicant

Paonan Biotech Co., Ltd.

Taipei, TW6 decisions2017–20230 recalls

FDA records 6 decisions for Paonan Biotech Co., Ltd. (Taipei, TW) from 2017 to 2023: 6 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 364 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 26 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 Paonan Biotech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12018: 12019: 32023: 1
2017high 3 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Paonan Biotech Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Paonan 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.

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • NKBThoracolumbosacral Pedicle Screw System2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 364 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 26 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 20191cites it
  • K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 20181cites it
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 20191cites it
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd. · 2023
  • K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd. · 2019
  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
  • K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017

All 6 as Paonan Biotech Co., Ltd. →