510(k) Report

FDA applicant

Newclip Technics

Haute-Goulaine, FR35 decisions2006–20260 recalls

FDA records 35 decisions for Newclip Technics (Haute-Goulaine, FR) from 2006 to 2026: 35 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and PBF (Orthopaedic Surgical Planning And Instrument…). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 128 predicates, 35 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 Newclip Technics’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2009: 12010: 12013: 12014: 12015: 22016: 32017: 52018: 42020: 12021: 22022: 12023: 12024: 22025: 32026 (partial year): 5
2007high 5 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Newclip Technics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone26decisions
  • PBFOrthopaedic Surgical Planning And Instrument Guides4decisions
  • HWCScrew, Fixation, Bone4decisions
  • HTYPin, Fixation, Smooth1decision

How long do its 510(k) reviews take?

Since 2016, its 27 510(k)s took a median of 92 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 15 of its 27 were faster than that.

Whose devices does it build on?

Its devices cite 128 predicates; 35 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 35 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.

  • K143061Activ Ankle Locking Plating SystemNewclip Technics · 20155cite it
  • K100944Clavicle Locking Plate SystemNewclip Technics · 20104cite it
  • K091118Foot and Hand Motion SystemNewclip Technics · 20094cite it
  • K161448Footmotion Plating SystemNewclip Technics · 20164cite it
  • K173641Activ AnkleNewclip Technics · 20183cite it
  • K152289Alians Elbow Locking Plating SystemNewclip Technics · 20163cite it

What has FDA decided for it lately?

  • K262649Alians ForearmNewclip Technics · 2026
  • K261511Xpert AnkleNewclip Technics · 2026
  • K261191Alians Elbow SNewclip Technics · 2026
  • K261038Xpert PFPNewclip Technics · 2026
  • K253906Xpert HandNewclip Technics · 2026
  • K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025
  • K250155Xpert KneeNewclip Technics · 2025
  • K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025

All 35 as Newclip Technics →