Cleared Traditional

Z1 Hip System (K233476) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233476 · Orchard Medical Development · Orthopedic device
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Feb 2024
Decision
106d
Days
Class 2
Risk

K233476 is an FDA 510(k) clearance for the Z1 Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Orchard Medical Development (Rosemont, US). The FDA issued a Cleared decision on February 8, 2024 after a review of 106 days - within the typical 510(k) review window.

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 Orchard Medical Development devices

Submission Details

510(k) Number K233476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2023
Decision Date February 08, 2024
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
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 308
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K233476.
22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
K234025 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2024
Ceramic Femoral Head
K240452 · Microport Orthopedics, Inc. · Apr 2024
28mm/38D MDM X3 Insert for MDM Liner
K233724 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Mar 2024
Novae® Dual Mobility System, Hype® Hip System
K223745 · Serf · Dec 2023
Actinia® hip stems
K232371 · Implantcast GmbH · Oct 2023
EMPHASYS Femoral Stems
K233233 · Depuy Ireland UC · Oct 2023