Cleared Traditional

K011810 - ORTHOGENESIS LPS PROXIMAL TIBIAL REPLAC...

K011810 is the FDA 510(k) clearance for ORTHOGENESIS LPS PROXIMAL TIBIAL REPLAC... by Depuy, Inc.. It is a Class 2 Orthopedic device (product code KRO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K011810 · Depuy, Inc. · Orthopedic device
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Sep 2001
Decision
88d
Days
Class 2
Risk

K011810 is an FDA 510(k) clearance for the ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 7, 2001 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 Depuy, Inc. devices

Submission Details

510(k) Number K011810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2001
Decision Date September 07, 2001
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 71
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K011810.
RT-PLUS KNEE ADDITIONAL COMPONENTS
K013340 · Plus Orthopedics · Dec 2001
MOST OPTIONS SYSTEM
K013031 · Sulzer Orthopedics, Inc. · Dec 2001
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · Wrightmedicaltechnologyinc · Dec 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504 · Plus Orthopedics · May 2001
AVL HINGE KNEE SYSTEM
K010774 · Biomet, Inc. · Apr 2001
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · Howmedica Osteonics Corp. · Nov 2000