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Apex Surgical, LLC

United StatesFDA applicant, unverified

Devices
6
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Apex Surgical, LLC makes

Apex Surgical, LLC manufactures modular hip arthroplasty components, including acetabular cups, femoral stems, and femoral heads made from zirconia and alumina ceramics. Their portfolio also includes a modular hip system designed for primary and revision surgeries, featuring hydroxyapatite-coated stems for enhanced osseointegration.

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database, reflecting their compliance with US medical device authorisation requirements.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

  • Apex Modular Acetabular Cup Ref K031110

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex Modular Hip Stem Ref K000788

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex Modular Zirconia Femoral Head Ref K003923

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex K2 Hip System Ref K041950

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex Modular Alumina Femoral Head Ref K012918

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex Modular Ha Hip Stem Ref K043123

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 6 recalls initiated by Apex Surgical, LLC, initiated on 2003-01-17. By recorded status: 6 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2003

    • 17 Jan 2003 Z-0713-04 Unclassified (pre-2012) Terminated Pilot shaft may break during reaming or broaching of the femur Distribution: CT, OH, FL, OK, TX, RI, NV, SC,
    • 17 Jan 2003 Z-0714-04 Unclassified (pre-2012) Terminated Pilot shaft may break during reaming or broaching of the femur Distribution: CT, OH, FL, OK, TX, RI, NV, SC,
    • 17 Jan 2003 Z-0715-04 Unclassified (pre-2012) Terminated Pilot shaft may break during reaming or broaching of the femur Distribution: CT, OH, FL, OK, TX, RI, NV, SC,
    • 17 Jan 2003 Z-0716-04 Unclassified (pre-2012) Terminated Pilot shaft may break during reaming or broaching of the femur Distribution: CT, OH, FL, OK, TX, RI, NV, SC,
    • 17 Jan 2003 Z-0717-04 Unclassified (pre-2012) Terminated Pilot shaft may break during reaming or broaching of the femur Distribution: CT, OH, FL, OK, TX, RI, NV, SC,
    • 17 Jan 2003 Z-0718-04 Unclassified (pre-2012) Terminated Pilot shaft may break during reaming or broaching of the femur Distribution: CT, OH, FL, OK, TX, RI, NV, SC,

Frequently asked questions

How many devices does Apex Surgical, LLC have in the registry?

The registry currently lists 6 devices for Apex Surgical, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Apex Surgical, LLC's devices?

Among its 6 most recently registered devices, Apex Surgical, LLC has devices listed in FDA 510(k) (6 devices).

What risk classes do Apex Surgical, LLC's devices fall under?

Among its 6 most recently registered devices, the classes recorded for Apex Surgical, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Apex Surgical, LLC?

FDA recall records list 6 recalls initiated by Apex Surgical, LLC, the most recent initiated on 17 Jan 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Apex Surgical, LLC in the registry?

The most recently registered devices listed for Apex Surgical, LLC include APEX MODULAR ACETABULAR CUP, APEX MODULAR HIP STEM, APEX MODULAR ZIRCONIA FEMORAL HEAD and APEX K2 HIP SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.