NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL— 510(k) K111572

Name: FDA 510(k) clearance K111572
Creator: U.S. Food and Drug Administration
Published: 2011-08-29

Substantially Equivalent

Serf

FDA 510(k) clearance K111572 for NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL, Substantially Equivalent on 2011-08-29. Applicant: Serf. Device class: 2.

Clearance details

Applicant: Serf
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2011-06-06
Decision date: 2011-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

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K253948 — Momentum Acetabular Cup System2026-09-02
K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
K260831 — Z1 Hip System2026-06-16
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30

More clearances from Serf

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K223745 — Novae® Dual Mobility System, Hype® Hip System2023-12-22
K181744 — BI-MENTUM dual mobility system2018-12-11
K142675 — CI../..X liner for NOVAE Dual Mobility Acetabular Cup2015-01-15

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K111572

K-number listed on FDA's recall record

Z-0920-2021 — SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128Class II·Terminated·OMNIlife science Inc.·20201221
Z-0921-2021 — SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728Class II·Terminated·OMNIlife science Inc.·20201221
Z-0922-2021 — SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928Class II·Terminated·OMNIlife science Inc.·20201221
Z-2479-2019 — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328Class II·Terminated·OMNIlife science Inc.·20190723
Z-2480-2019 — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128Class II·Terminated·OMNIlife science Inc.·20190723

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111572.

Data sourced from openFDA. This site is unofficial and independent of the FDA.