Cleared Traditional

K013106 - 2 PIECE MODULAR HIP STEM

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

K013106 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K013106

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.

LZO Device Classification - Class 2, Special Controls

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 508
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
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · Smith & Nephew, Inc. · Jun 2002
MS-30 LATERAL FEMORAL STEM
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