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Total Hip Prosthesis System Quadra S + CoCrMo Femoral Ball Head + Apricot

by Medacta International S.A.

510(k) K072857

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072857 Date4 Feb 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0791-2013 FDA Class II initiated 17 Dec 2012 on shared 510(k) K072857

    The tip of the Quadra Trial Broach size 0, broke during a surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Total Hip Prosthesis System Quadra S is a cementless, semi-constrained hip replacement system designed for use in total or partial hip arthroplasty. It comprises a femoral stem, CoCrMo femoral ball head, and an Apricot cup system, combining metal and polymer components to restore hip function. The system is intended for both primary and revision surgeries, providing structural support and articulation for the hip joint. Its semi-constrained design offers stability while allowing controlled movement, suitable for patients requiring hip reconstruction.

This system is supplied sterile and intended for single-use in orthopedic surgical settings. The CoCrMo femoral ball head and Apricot cup are paired with the Quadra S femoral stem, adhering to FDA-cleared specifications under 510(k) K072857. The device is classified under classification name Prosthesis, Hip, Semi-constrained, Metal/polymer and is regulated under 21 CFR 888.3350. Storage and handling must comply with sterile surgical instrument protocols to ensure integrity prior to use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Quadra S Total Hip Prosthesis System used for?

    The Quadra S Total Hip Prosthesis System is designed for total or partial hip arthroplasty, serving both primary and revision surgeries. Its semi-constrained design provides stability while allowing controlled movement, making it suitable for patients requiring hip reconstruction. The system combines a cementless femoral stem, a cobalt-chromium-molybdenum (CoCrMo) femoral ball head, and an Apricot cup to restore hip function.

  • How is the Quadra S system supplied and intended for use?

    The Quadra S system is supplied sterile and intended exclusively for single-use in orthopedic surgical settings. This ensures patient safety and compliance with sterile surgical protocols, preventing contamination or reuse-related risks. The components—femoral stem, CoCrMo ball head, and Apricot cup—are paired according to FDA-cleared specifications.

  • Is the Quadra S system reusable or single-use?

    The Quadra S system is explicitly intended for single-use only. This design choice aligns with sterile surgical standards to minimize infection risks and ensure optimal performance. Reuse is not recommended or supported by the manufacturer or regulatory clearance.

  • What materials are used in the Quadra S system?

    The system features a cobalt-chromium-molybdenum (CoCrMo) femoral ball head paired with an Apricot cup system, which combines metal and polymer components. The femoral stem is designed for cementless fixation, allowing osseointegration with the bone. These materials are chosen for durability, biocompatibility, and stability in hip arthroplasty.

  • How should the Quadra S system be stored?

    The Quadra S system must be stored and handled according to sterile surgical instrument protocols to maintain its integrity before use. Proper storage conditions—such as sealed packaging, controlled humidity, and protection from physical damage—are critical to preserving sterility and functionality. Always follow manufacturer guidelines for unpacking and preparation in the operating room.