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Global Taper Spectron Hip Stems

by Smith & Nephew, Inc., Orthopaedic Div.

510(k) K970351

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 NumberK970351 Date28 Feb 1997ClearedStatusActive

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  • Withdrawn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, 19 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 Global Taper Spectron Hip Stems are classified as Hip Prosthesis (FDA Product Code: JDI) and designed for use in primary and revision hip arthroplasty procedures. Constructed from forged cobalt-chrome alloy, these stems feature a unique taper geometry intended to enhance stability and fixation within the femoral canal. The design supports both cemented and uncemented applications, providing versatility for surgical approaches.

These stems are supplied as part of a single-tray instrumentation system, including broach-only tools for streamlined surgical workflows. They are intended for reusable use in sterile environments, with no explicit MRI safety labeling provided. Authorized under FDA 510(k) clearance (K970351) as substantially equivalent to a predicate device, they adhere to traditional review standards for orthopedic implants. Storage and handling follow standard orthopedic implant protocols.

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