Cleared Traditional

K233476 - Z1 Hip System

K233476 is an FDA 510(k) clearance for Z1 Hip System, manufactured by Orchard Medical Development. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K233476 · Orchard Medical Development · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K233476

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.

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 473
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K233476.
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