Cleared Traditional

K211657 - EMPHASYS Femoral Stems

K211657 is the FDA 510(k) clearance for EMPHASYS Femoral Stems by Depuy Ireland UC. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K211657 · Depuy Ireland UC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2021
Decision
69d
Days
Class 2
Risk

K211657 is an FDA 510(k) clearance for the EMPHASYS 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 Depuy Ireland UC (Loughbeg, IE). The FDA issued a Cleared decision on August 5, 2021 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Ireland UC devices

Submission Details

510(k) Number K211657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2021
Decision Date August 05, 2021
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 Consultant

Depuy Synthes, Irenc.
Clare Hill

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 421
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K211657.
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