510(k) Report

FDA applicant

Enztec Limited

Middleton, NZ5 decisions2021–20230 recalls

FDA records 5 decisions for Enztec Limited (Middleton, NZ) from 2021 to 2023: 5 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 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 Enztec Limited’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2021: 12022: 12023: 3
2021high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Enztec Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Enztec Limited’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, Lumbar4decisions
  • OLOOrthopedic Stereotaxic Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited · 20212cite it
  • K223671CONDUIT LLIF Straight InsertersEnztec Limited · 20231cites it

What has FDA decided for it lately?

  • K232014CONDUIT™ ATP InsertersEnztec Limited · 2023
  • K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited · 2023
  • K223671CONDUIT LLIF Straight InsertersEnztec Limited · 2023
  • K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited · 2022
  • K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited · 2021

All 5 as Enztec Limited →