Cleared Traditional

ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS (K053293) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053293 · Ortho Development Corp. · Orthopedic device
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Feb 2006
Decision
83d
Days
Class 2
Risk

K053293 is an FDA 510(k) clearance for the ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on February 16, 2006 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho Development Corp. devices

Submission Details

510(k) Number K053293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date February 16, 2006
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K053293.
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · Smith & Nephew, Inc. · Jun 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581 · DePuy Orthopaedics, Inc. · May 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040 · Zimmer, Inc. · May 2006
VERSYS EPOCH FULLCOAT HIP PROSTHESIS
K052321 · Zimmer, Inc. · Feb 2006
DEPUY MODULAR M HEADS
K060031 · DePuy Orthopaedics, Inc. · Jan 2006
LINEAGE A-CLASS POLY LINER
K052026 · Wrightmedicaltechnologyinc · Dec 2005