510(k) Report

FDA applicant

Safe Orthopaedics

Eragny Sur Oise, FR13 decisions2011–20201 recall

FDA records 13 decisions for Safe Orthopaedics (Eragny Sur Oise, FR) from 2011 to 2020: 13 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 42 days from receipt to decision, against 69 for FDA’s reviews in the same codes and years. Its devices cite 40 predicates, 30 of them its own earlier devices. 1 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 Safe Orthopaedics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011: 12012: 22013: 12014: 22015: 42016: 12017: 12020: 1
2011high 4 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2011high 1 (2022) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Safe Orthopaedics by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System9decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 42 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 69 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 40 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 30 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.

  • K112453Sterispineps Pedicle ScrewSafe Orthopaedics · 20119cite it
  • K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 20125cite it
  • K130632Sterispine PS Pedicle ScrewSafe Orthopaedics · 20134cite it
  • K140802Sterispine PSSafe Orthopaedics · 20143cite it
  • K151747Sterispine PSSafe Orthopaedics · 20152cite it
  • K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics · 20152cite it

What has FDA decided for it lately?

  • K201648Sterispine™ PSSafe Orthopaedics · 20201 recall
  • K170528Sterispine™ PSSafe Orthopaedics · 2017
  • K162531Sterispine CCSafe Orthopaedics · 2016
  • K151921Sterispine PSSafe Orthopaedics · 2015
  • K151747Sterispine PSSafe Orthopaedics · 2015
  • K151756Sterispine LC CageSafe Orthopaedics · 2015
  • K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics · 2015
  • K140802Sterispine PSSafe Orthopaedics · 2014

All 13 as Safe Orthopaedics →

What has been recalled?

1 recall linked to its devices; the latest:

  • K201648SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers…Jun 3, 2022Class II

Other applicant names beginning “Safe”

FDA records each applicant name separately; these may or may not be the same firm.

Safe Shield Co., Ltd. 2Safe Tech Medical Products, Inc. 2Safe-Tec Clinical Products, Inc. 2Safe Secure Packaging Co., Ltd. 2Safe Glove, Ltd. 2Safe Obstetric Systems, Ltd. 1Safe Product Supplies 1Safe T Medical Devices, Ltd. 1Safe Secure Packing Co., Ltd. 1Safe Restraints, Inc. 1Safe Sun Corporation of America, Inc. 1Safe Bvm Corporation 1