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Exactech Equinoxe Shoulder System

by Exactech, Inc.

510(k) K042021

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 ongoing

This device is named in the recall

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 NumberK042021 Date26 Oct 2004ClearedStatusActive

Recalls

10 recalls · 8 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0536-2026 FDA Class II initiated 5 Sep 2025 on shared 510(k) K042021
    • Ongoing Z-0535-2026 FDA Class II initiated 5 Sep 2025 on shared 510(k) K042021
    • Ongoing Z-0537-2026 FDA Class II initiated 5 Sep 2025 on shared 510(k) K042021

    Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

  • 4 recalls, same reason

    • Ongoing Z-1404-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1402-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1405-2024 FDA Class II initiated 6 Mar 2024
    • Ongoing Z-1403-2024 FDA Class II initiated 6 Mar 2024

    The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

    • Ongoing Z-0884-2021 FDA Class II initiated 9 Nov 2020 on shared 510(k) K042021

    Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

    • Terminated Z-1459-2015 FDA Class II initiated 13 Feb 2015

    Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

    • Terminated Z-2115-2012 FDA Class II initiated 15 Jun 2012

    Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year

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
KWS
Device class
Class II
Regulation
21 CFR Part 888.3660
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Exactech Equinoxe Shoulder System is a cemented or non-cemented shoulder prosthesis designed for shoulder replacement. It is intended to address challenges and complications associated with reverse shoulder arthroplasty, as identified during the product development process by Exactech, Inc.

The system received FDA 510(k) clearance (K042021) on October 26, 2004, and is classified under product code KWS with an orthopedic advisory committee review. It is supplied as a prosthesis for surgical implantation and is not described as sterile, single-use, reusable, or MRI safe in the provided data; no storage conditions or size specifications are included in the device data.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Questions

AI-generated answers, 22 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 is the Exactech Equinoxe Shoulder System used for?

    The Exactech Equinoxe Shoulder System is a cemented or non-cemented shoulder prosthesis designed for shoulder replacement, intended to address challenges and complications associated with reverse shoulder arthroplasty as identified during product development by Exactech, Inc.

  • How is the Exactech Equinoxe Shoulder System supplied?

    The system is supplied as a prosthesis for surgical implantation, as stated in the device data, with no indication of sterility, single-use, reusable, or MRI safety characteristics provided.

  • What regulatory pathway was used for the Exactech Equinoxe Shoulder System?

    The Exactech Equinoxe Shoulder System received FDA 510(k) clearance under K042021 on October 26, 2004, and was found substantially equivalent, with review by the orthopedic advisory committee under product code KWS.