Cleared Traditional

K011533 - DEPUY FEMORAL HEADS

K011533 is an FDA 510(k) clearance for DEPUY FEMORAL HEADS, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K011533 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
255d
Days
Class 2
Risk

K011533 is an FDA 510(k) clearance for the DEPUY FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 28, 2002 after a review of 255 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K011533

510(k) Number K011533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2001
Decision Date January 28, 2002
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
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 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K011533.
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · Smith & Nephew, Inc. · Jun 2002
MS-30 LATERAL FEMORAL STEM
K020713 · Sulzer Orthopedics, Inc. · May 2002
2 PIECE MODULAR HIP STEM
K013106 · Howmedica Osteonics Corp. · Apr 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
PRO-FEMUR
K012091 · Wrightmedicaltechnologyinc · Oct 2001