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Exactech Total Hip System

by Exactech, Inc.

510(k) K862234

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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)SN Traditional NumberK862234 Date15 Oct 1986DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
SN

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 Total Hip System is a comprehensive range of femoral stems, acetabular components, and surgical instrumentation designed for primary and revision total hip arthroplasty. This system provides options for hip replacement surgery, including various components to meet different surgical needs.

The system is supplied as a medical device with FDA 510(k) clearance under product code JDI, with the K-number K862234. It is manufactured by Exactech, Inc. in Gainesville, Florida, and is intended for use in total hip replacement procedures, though specific indications may vary based on the components selected.

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 Total Hip System used for?

    The Exactech Total Hip System is designed for primary and revision total hip arthroplasty procedures, providing various components to meet different surgical needs in hip replacement surgery.

  • How is the Exactech Total Hip System supplied?

    The system is supplied as a medical device with FDA 510(k) clearance under product code JDI, with K-number K862234, manufactured by Exactech, Inc. in Gainesville, Florida.

  • What components are included in the Exactech Total Hip System?

    The system includes a comprehensive range of femoral stems, acetabular components, and surgical instrumentation designed to provide options for hip replacement surgery based on different surgical requirements.

  • What is the regulatory status of the Exactech Total Hip System?

    The Exactech Total Hip System has FDA 510(k) clearance under product code JDI with K-number K862234, and is classified as substantially equivalent for some indications by the Orthopedic advisory committee.