Cleared Traditional

Z1 Cemented Hip System (K241241) - FDA 510(k) Clearance

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

K241241 · Orchard Medical Development, LLC · Orthopedic device
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Aug 2024
Decision
116d
Days
Class 2
Risk

K241241 is an FDA 510(k) clearance for the Z1 Cemented 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, LLC (Rosemont, US). The FDA issued a Cleared decision on August 27, 2024 after a review of 116 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, LLC devices

Submission Details

510(k) Number K241241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2024
Decision Date August 27, 2024
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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

Secure BioMed Evaluations
Justin Gracyalny

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 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K241241.
b-ONE® Total Hip System
K240528 · B-One Ortho, Corp. · Nov 2024
MUTARS® femoral stem cemented 160 mm and 200 mm
K240391 · Implantcast GmbH · Oct 2024
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K242249 · United Orthopedic Corporation · Aug 2024
CATALYSTEM Femoral Stems
K240381 · Smith & Nephew, Inc. · Jun 2024
EcoFit® short stem cementless cpTi
K240834 · Implantcast GmbH · Jun 2024
22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
K234025 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2024