Cleared Traditional

K153216 - Alpine Cemented Hip System

K153216 is an FDA 510(k) clearance for Alpine Cemented Hip System, manufactured by Ortho Development Corporation. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K153216

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
Combination Product No
PCCP Authorized No
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.

JDI Device Classification - Class 2, Special Controls

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 521
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K153216.
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
FitRite™ Total Hip Arthroplasty System
K153057 · Excera Orthopedics, Inc. · Jun 2016
Corin TaperFit Hip Stem
K153725 · Corin U.S.A. Limited · Mar 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
K142814 · Biomet Manufacturing, LLC · Jun 2015
Corin TaperFit Hip Stem
K142761 · Corin USA · Apr 2015