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510(k) Data Aggregation

    K Number
    K252067

    Validate with FDA (Live)

    Device Name
    Velora Acetabular System
    Manufacturer
    Restor3D, Inc.
    Date Cleared
    2025-12-05

    (157 days)

    Product Code
    LPH,LZO,MEH,OQG
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K190904,K243977,K190660
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Velora Acetabular System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:

    • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
    • Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
    • Revision procedures for failed previous hip surgery (excluding situations where hardware is present).

    The implants in the Velora Acetabular System are intended for cementless fixation using an anterior or posterior surgical approach.

    Device Description

    This submission introduces the Velora Acetabular System, which consists of acetabular cups that are additively manufactured from titanium alloy (Ti-6Al-4V per ASTM F2924) with an integrally built 3D-printed porous structure (TIDAL Technology) and standardized polyethylene (ASTM F2695, ASTM F2565) liners. The liners are available in standard offset, lateral offset, lipped, and face-changing geometries. The cups are provided in sizes 40mm to 72mm, and the mating liners are provided in sizes from Grp A to Grp K, as outlined in the table below. There are additional single-use trial liners and reusable instruments offered with the Velora Acetabular System. The Velora Acetabular System devices are compatible with the previously cleared Conformis Actera (K231178) and Cordera (K192198) femoral implants, acetabular screws, and reusable instruments.

    AI/ML Overview

    N/A

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