Cleared Traditional

K121024 - LINEAR POROUS COATED HIP STEM

Also marketed or referenced as:
REVELATION HIP STEM, SIZE 8 FOUNDATION POROUS PRESS FIT STEM, SIZE 8

K121024 is the FDA 510(k) clearance for LINEAR POROUS COATED HIP STEM by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K121024 · Encore Medical, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
76d
Days
Class 2
Risk

K121024 is an FDA 510(k) clearance for the LINEAR POROUS COATED HIP STEM, SIZE 5. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on June 19, 2012 after a review of 76 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 Encore Medical, L.P. devices

Submission Details

510(k) Number K121024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2012
Decision Date June 19, 2012
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 442
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K121024.
POLARCUP DUAL MOBILITY SYSTEM
K122244 · Smith & Nephew, Inc. · Aug 2012
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K120030 · Biomet Manufacturing Corp · Aug 2012
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K121308 · Howmedica Osteonics Corp. · Jul 2012
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
K112158 · Lima Corporate S.P.A. · May 2012
LINEAR HIP STEM, SIZE 5
K120241 · Encore Medical, L.P. · Feb 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · Exactech, Inc. · Jan 2012