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Intrinsic Stem

by Turnkey Intergration USA, Inc. 510(k)

Active United States

510(k) K923911

Overview

The Intrinsic Stem is a femoral component classified as an Orthopedic Intramedullary Nail (Product Code LWJ), designed for internal fixation of femoral fractures. It provides structural support to stabilize long-bone fractures by being inserted into the medullary cavity of the femur, ensuring proper alignment and promoting bone healing through rigid fixation.

This device is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance under the Traditional pathway. It is intended for use in orthopedic surgical settings and must be handled and stored according to manufacturer guidelines to maintain sterility. The Intrinsic Stem was cleared under the Orthopedic Advisory Committee (OR) and is identified by the FDA with the clearance number K923911.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923911 Date14 Apr 1993ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
LWJ
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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