Cleared Traditional

K221462 - DePuy Reclaim Monobloc Revision Femoral...

K221462 is the FDA 510(k) clearance for DePuy Reclaim Monobloc Revision Femoral... by Depuy Ireland UC. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K221462 · Depuy Ireland UC · Orthopedic device
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Oct 2022
Decision
155d
Days
Class 2
Risk

K221462 is an FDA 510(k) clearance for the DePuy 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 (Loughbeg, IE). The FDA issued a Cleared decision on October 21, 2022 after a review of 155 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy Ireland UC devices

Submission Details

510(k) Number K221462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2022
Decision Date October 21, 2022
Days to Decision 155 days
Submission Type Traditional
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
33d slower than avg
Panel avg: 122d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 420
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