Cleared Special

K251292 - RECLAIM Monobloc Revision Femoral Stem

K251292 is an FDA 510(k) clearance for RECLAIM Monobloc Revision Femoral Stem, manufactured by Depuy Ireland UC. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 28-day FDA review.

K251292 · Depuy Ireland UC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
28d
Days
Class 2
Risk

K251292 is an FDA 510(k) clearance for the RECLAIM Monobloc Revision Femoral Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on May 23, 2025 after a review of 28 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 - K251292

510(k) Number K251292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2025
Decision Date May 23, 2025
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K251292.
Coated hip implants
K250450 · Medacta International S.A. · Sep 2025
Longboard Revision Hip Stem
K243021 · Signature Orthopaedics Pty, Ltd. · Aug 2025
Z1 Hip System
K251906 · Zimmer, Inc. · Jul 2025
MobileLink Acetabular Cup System - inhouse coatings
K243927 · Waldemar Link GmbH & Co. KG · May 2025
NEXUS® Hip Stem
K250444 · Microport Orthopedics, Inc. · May 2025
Origin™ Cemented Hip Stem
K243043 · Signature Orthopaedics Pty, Ltd. · May 2025
K251292 · RECLAIM Monobloc Revision Femoral Stem
Download PDF FDA Summary Depuy Ireland UC