510(k) Report

FDA applicant

Serf

Decines, FR4 decisions2011–20235 recalls

FDA records 4 decisions for Serf (Decines, FR) from 2011 to 2023: 4 510(k) clearances. All are in product code LZO (Prosthesis, Hip, Semi-Constrained…). Its devices cite 17 predicates, 4 of them its own earlier devices. 5 recalls are 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 Serf’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011: 12015: 12018: 12023: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

3in 2020

2019: 22020: 3
2011high 3 (2020) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Serf 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?

  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…4decisions

Whose devices does it build on?

Its devices cite 17 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 4 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.

  • K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility…Serf · 201110cite it
  • K181744BI-MENTUM dual mobility systemSerf · 20183cite it
  • K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf · 20152cite it
  • K223745Novae® Dual Mobility System, Hype® Hip SystemSerf · 20231cites it

What has FDA decided for it lately?

  • K223745Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023
  • K181744BI-MENTUM dual mobility systemSerf · 2018
  • K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf · 2015
  • K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility…Serf · 20115 recalls

All 4 as Serf →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K111572SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with…Dec 21, 2020Class II
  • K111572SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with…Dec 21, 2020Class II
  • K111572SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the…Dec 21, 2020Class II
  • K111572OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility…Jul 23, 2019Class II
  • K111572OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility…Jul 23, 2019Class II