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Lester Press Fit Hip Prosthesis

by Kirschner Medical Corp. 510(k)

Active United States

510(k) K915500

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915500 Date20 Oct 1992ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 6 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 Lester Press Fit Hip Prosthesis is a semi-constrained, metal/polymer, cemented hip prosthesis designed for orthopedic use. It is intended to replace damaged or diseased hip joints to restore mobility and function.

This device is supplied as a single-use implant and is not MRI safe. It is stored according to manufacturer guidelines and has received FDA 510(k) clearance with the product code JDI. The device is available in various sizes as specified by the model numbers.

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