Cleared Special

K250571 - CATALYSTEM Femoral Stems

K250571 is an FDA 510(k) clearance for CATALYSTEM Femoral Stems, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 30-day FDA review.

K250571 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
30d
Days
Class 2
Risk

K250571 is an FDA 510(k) clearance for the CATALYSTEM Femoral Stems. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 28, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K250571

510(k) Number K250571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2025
Decision Date March 28, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 533
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K250571.
NEXUS® Hip Stem
K250444 · Microport Orthopedics, Inc. · May 2025
Origin™ Cemented Hip Stem
K243043 · Signature Orthopaedics Pty, Ltd. · May 2025
Zimmer Biomet Ceramic Heads (22.2mm diameter)
K250834 · Zimmer Biomet · Apr 2025
Origin™ TT Stem
K243029 · Signature Orthopaedics Pty, Ltd. · Mar 2025
Versacem Acetabular Shell and Double Mobility HC Liners
K241767 · Medacta International S.A. · Mar 2025
Biolox® Delta Revision heads
K243809 · Limacorporate · Mar 2025
K250571 · CATALYSTEM Femoral Stems
Download PDF FDA Summary Smith & Nephew, Inc.