Cleared Traditional

FOUNDATION POROUS HIP STEM (K991226) - FDA 510(k) Clearance

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

K991226 · Encore Orthopedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 1999
Decision
50d
Days
Class 2
Risk

K991226 is an FDA 510(k) clearance for the FOUNDATION POROUS HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 1, 1999 after a review of 50 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

Submission Details

510(k) Number K991226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date June 01, 1999
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K991226.
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · Smith & Nephew, Inc. · Jan 2000
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
K991708 · Biomet, Inc. · Jul 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
K991952 · Howmedica Osteonics Corp. · Jun 1999
TYPE 3 FEMORAL COMPONENTS
K983404 · Howmedica Corp. · Dec 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · Smith & Nephew, Inc. · Jul 1998
OSTEOLOCK ACETABULAR CUP
K981201 · Howmedica Corp. · May 1998