Cleared Traditional

K141001 - ALPINE HIP STEM

Also marketed or referenced as:
ALPINE HA HIP STEM

K141001 is an FDA 510(k) clearance for ALPINE HIP STEM, manufactured by Ortho Development. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K141001 · Ortho Development · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
103d
Days
Class 2
Risk

K141001 is an FDA 510(k) clearance for the ALPINE HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Ortho Development (Draper, US). The FDA issued a Cleared decision on July 30, 2014 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 devices

FDA 510(k) Submission Details - K141001

510(k) Number K141001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2014
Decision Date July 30, 2014
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 478
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K141001.
Echo Bi-Metric Microplasty Hip System
K143009 · Biomet, Inc. · Dec 2014
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Restoration Anatomic Shell
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ALTEON 6.5MM BONE SCREWS
K141797 · Exactech, Inc. · Jul 2014
DELTA TT ACETABULAR SYSTEM
K141395 · Lima Corporate S.P.A. · Jun 2014
ENCOMPASS 10/12 HIP STEM
K132697 · Ortho Development Corp. · Jun 2014