Cleared Traditional

K993943 - ENCORE LINEAR POROUS COATED HIP WITH HA

K993943 is an FDA 510(k) clearance for ENCORE LINEAR POROUS COATED HIP WITH HA, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K993943 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
77d
Days
Class 2
Risk

K993943 is an FDA 510(k) clearance for the ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA.... Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 77 days - a notably fast clearance 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: 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K993943

510(k) Number K993943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1999
Decision Date February 04, 2000
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 132
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K993943.
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