Cleared Traditional

K935193 - CONSENSUS HIP SYSTEM- POROUS COATED TIT...

K935193 is an FDA 510(k) clearance for CONSENSUS HIP SYSTEM- POROUS COATED TIT..., manufactured by U.S. Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K935193 · U.S. Medical Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
296d
Days
Class 2
Risk

K935193 is an FDA 510(k) clearance for the CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by U.S. Medical Products, Inc. (Austin, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 296 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 U.S. Medical Products, Inc. devices

FDA 510(k) Submission Details - K935193

510(k) Number K935193 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 26, 1993
Decision Date August 18, 1994
Days to Decision 296 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 122d · This submission: 296d
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 K935193.
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · Biomet, Inc. · Oct 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942 · Depuy, Inc. · Oct 1994
APR II FEMORAL COMPONENT (VARIOUS)
K942330 · Intermedics Orthopedics · Oct 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
K941847 · Depuy, Inc. · Jul 1994
SOLUTION HIP
K941942 · Depuy, Inc. · Jul 1994
STABILITY HIP STEM WITH POROCOAT
K934457 · Depuy, Inc. · Jul 1994