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ASR XL Modular Acetabular Cup System

by Depuy Orthopaedics, Inc.

510(k) K080991

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

41 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 NumberK080991 Date2 Jul 2008ClearedStatusActive

Recalls

41 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1815-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1811-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1807-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1806-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1812-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1816-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1809-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1805-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1814-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1810-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1813-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
    • Terminated Z-1808-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010

    As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

  • 29 recalls, same reason

    • Terminated Z-2056-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-203-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2042-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2055-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2059-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2036-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2051-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2031-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2038-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2054-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2047-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2044-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2048-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2045-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2035-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2053-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2052-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2049-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2040-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2057-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2041-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2050-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2058-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2043-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2046-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2037-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2033-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2039-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010
    • Terminated Z-2032-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010

    Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-m

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Depuy Asr Xl Modular Acetabular Cup System
510(k) Number
FDA Product Code
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The ASR XL Modular Acetabular Cup System is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for use in total hip arthroplasty. It features a modular, metal-based acetabular cup intended to provide stable fixation within the pelvis, accommodating various acetabular geometries and orientations through modular components.

This system is supplied as a sterile, single-use orthopedic implant intended for surgical use in controlled operating room environments. It is classified as a Class III device under FDA regulations and requires pre-market approval. Multiple component sizes and configurations are available to match patient anatomy, with specific part numbers listed in the regulatory submission.

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Questions

AI-generated answers, 18 Sep 2026

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

  • What types of patients is the DePuy ASR XL Modular Acetabular Cup System designed to accommodate in terms of anatomical variability?

    The DePuy ASR XL Modular Acetabular Cup System is engineered to address a range of acetabular geometries and orientations through its modular design. This flexibility allows surgeons to match the implant to individual patient anatomy, ensuring stable fixation within the pelvis during total hip arthroplasty procedures.

  • Is the DePuy ASR XL Modular Acetabular Cup System intended for reuse in multiple surgeries, or is it meant for single-use only?

    The DePuy ASR XL Modular Acetabular Cup System is explicitly supplied as a sterile, single-use orthopedic implant. It is intended for use in controlled operating room environments during a single surgical procedure, adhering to standard orthopedic implant protocols.

  • How many different sizes or configurations are available for the DePuy ASR XL Modular Acetabular Cup System, and how are they identified?

    The system includes multiple component sizes and configurations to match patient anatomy, with each variant identified by specific part numbers listed in the regulatory submission. These part numbers correspond to distinct acetabular cup designs and modular components, ensuring compatibility with various surgical needs.

  • What kind of regulatory pathway was followed for the FDA clearance of the DePuy ASR XL Modular Acetabular Cup System, and what does this imply for its use?

    The DePuy ASR XL Modular Acetabular Cup System underwent a traditional 510(k) clearance process through the FDA, classified as substantially equivalent under the Orthopedic specialty category. This pathway confirms that the device meets FDA standards for safety and effectiveness as a semi-constrained metal uncemented acetabular component in total hip arthroplasty, ensuring compliance with regulatory requirements for its intended surgical use.

  • How should the DePuy ASR XL Modular Acetabular Cup System be stored before use, given its sterile and single-use nature?

    Since the system is sterile and single-use, it must be stored in its original packaging under conditions that maintain sterility until the time of surgery. Proper storage typically involves keeping the components in a clean, dry environment, protected from contamination, and adhering to manufacturer guidelines to preserve integrity for use in controlled operating room settings.