Cleared Traditional

K013106 - 2 PIECE MODULAR HIP STEM

K013106 is the FDA 510(k) clearance for 2 PIECE MODULAR HIP STEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K013106 · Howmedica Osteonics Corp. · Orthopedic device
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Apr 2002
Decision
198d
Days
Class 2
Risk

K013106 is an FDA 510(k) clearance for the 2 PIECE MODULAR HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 3, 2002 after a review of 198 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K013106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2001
Decision Date April 03, 2002
Days to Decision 198 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
76d slower than avg
Panel avg: 122d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K013106.
MPF ACETABULAR CUP GENERATION 2
K022120 · Plus Orthopedics · Jul 2002
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K020713 · Sulzer Orthopedics, Inc. · May 2002
DEPUY FEMORAL HEADS
K011533 · DePuy Orthopaedics, Inc. · Jan 2002
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · Smith & Nephew, Inc. · Dec 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · Sulzer Orthopedics, Inc. · Dec 2001