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Hss Femoral Components

by Hospital For Special Surgery

510(k) K934857

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)SESE Substantially Equivalent · Traditional NumberK934857 Date18 Jul 1995ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Hss Femoral Components are orthopedic devices designed for use in surgical procedures. These components are intended to function as part of a femoral replacement system.

This device is identified by K-number K934857 and has received FDA 510(k) clearance. It is classified under product code JDI and was reviewed by the orthopedic advisory committee.

Other devices from Hospital For Special Surgery

Questions

AI-generated answers, 25 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 intended use of the HSS Femoral Components?

    These components are designed to be used as part of a femoral replacement system during orthopedic surgical procedures to restore function to the hip joint.

  • What is the regulatory status of this device?

    The HSS Femoral Components have received FDA 510(k) clearance under K-number K934857, confirming that the device has been found substantially equivalent to legally marketed predicate devices.

  • How is this device classified for regulatory purposes?

    The device is classified under product code JDI and was reviewed by the orthopedic advisory committee to ensure it meets the necessary standards for its intended surgical application.