Cleared Traditional

Alpine Cemented Hip System (K153216) - FDA 510(k) Clearance

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

K153216 · Ortho Development Corporation · Orthopedic device
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Feb 2016
Decision
105d
Days
Class 2
Risk

K153216 is an FDA 510(k) clearance for the Alpine Cemented Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on February 18, 2016 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Ortho Development Corporation devices

Submission Details

510(k) Number K153216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2015
Decision Date February 18, 2016
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K153216.
Cemented TSI Hip Stem
K181340 · Signature Orthopaedics Pty, Ltd. · Feb 2019
Libertas Hip Replacement System
K180973 · Maxx Orthopedics, Inc. · Sep 2018
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · Biomet, Inc. · Oct 2014
Sirius Femoral Stem, Size 30A
K142295 · Biomet, Inc. · Sep 2014