Cleared Traditional

K132158 - NOVOHIP TOTAL HIP SYSTEM

K132158 is an FDA 510(k) clearance for NOVOHIP TOTAL HIP SYSTEM, manufactured by Novosource, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K132158 · Novosource, Inc. · Orthopedic device
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Feb 2014
Decision
224d
Days
Class 2
Risk

K132158 is an FDA 510(k) clearance for the NOVOHIP TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Novosource, Inc. (Dayton, US). The FDA issued a Cleared decision on February 21, 2014 after a review of 224 days - an extended review cycle.

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 Novosource, Inc. devices

FDA 510(k) Submission Details - K132158

510(k) Number K132158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2013
Decision Date February 21, 2014
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
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 K132158.
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
K133832 · Total Joint Orthopedics, Inc. · Mar 2014
OVATION TRIBUTE HIP STEM
K133386 · Ortho Development Corp. · Mar 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959 · DePuy Orthopaedics, Inc. · Mar 2014
KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
K131454 · Total Joint Orthopedics, Inc. · Feb 2014
MPACT EXTENSION
K132879 · Medacta International · Jan 2014
OVATION 10/12 HIP STEM
K131022 · Ortho Development Corp. · Oct 2013