Cleared Traditional

K935453 - CONSENSUS(TM) HIP SYSTEM-HA COATED TIAN...

K935453 is an FDA 510(k) clearance for CONSENSUS(TM) HIP SYSTEM-HA COATED TIAN..., manufactured by U.S. Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K935453 · U.S. Medical Products, Inc. · Orthopedic device
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Jul 1994
Decision
243d
Days
Class 2
Risk

K935453 is an FDA 510(k) clearance for the CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by U.S. Medical Products, Inc. (Austin, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 243 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 - K935453

510(k) Number K935453 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 12, 1993
Decision Date July 13, 1994
Days to Decision 243 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
121d slower than avg
Panel avg: 122d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 134
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K935453.
RESTORATION HA ACETABULAR CUP SERIES
K943957 · Osteonics Corp. · Mar 1995
SUMMIT TOTAL HIP SYSTEM
K942891 · Kirschner Medical Corp. · Nov 1994
TECHMEDICA CONTINUUM HIP WITH HA COATING
K932017 · Techmedica, Inc. · Sep 1994
F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
K935990 · Implex Corp. · Jul 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K922621 · Smith & Nephew Richards, Inc. · Mar 1994
STABILITY FEMORAL PROSTHESIS W/HAP
K915655 · Depuy, Inc. · Feb 1994