Cleared Traditional

K130353 - PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)

K130353 is an FDA 510(k) clearance for PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION), manufactured by Pipeline Orthopedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K130353 · Pipeline Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
139d
Days
Class 2
Risk

K130353 is an FDA 510(k) clearance for the PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION). Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Pipeline Orthopedics (Alexandria, US). The FDA issued a Cleared decision on July 1, 2013 after a review of 139 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 Pipeline Orthopedics devices

FDA 510(k) Submission Details - K130353

510(k) Number K130353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2013
Decision Date July 01, 2013
Days to Decision 139 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 slower than avg
Panel avg: 122d · This submission: 139d
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 485
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K130353.
MPACT EXTENSION
K132879 · Medacta International · Jan 2014
OVATION 10/12 HIP STEM
K131022 · Ortho Development Corp. · Oct 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
K132207 · United Orthopedic Corporation · Aug 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · Encore Medical, L.P. · Jun 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149 · United Orthopedic Corporation · Jun 2013
UTF STEM, REDUCED
K123550 · United Orthopedic Corporation · May 2013