Cleared Traditional

K915192 - 7000 SERIES MODULAR TIBIAL COMPONENTS

K915192 is the FDA 510(k) clearance for 7000 SERIES MODULAR TIBIAL COMPONENTS by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K915192 · Osteonics Corp. · Orthopedic device
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Feb 1992
Decision
87d
Days
Class 2
Risk

K915192 is an FDA 510(k) clearance for the 7000 SERIES MODULAR TIBIAL COMPONENTS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Osteonics Corp. devices

Submission Details

510(k) Number K915192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date February 14, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K915192.
OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION
K920524 · Osteonics Corp. · May 1992
CONTINUUM KNEE SYSTEM (CKS)
K914072 · Techmedica, Inc. · Feb 1992
7000 SERIES TOTAL KNEE PATELLAR COMPONENTS
K915186 · Osteonics Corp. · Feb 1992
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM
K915132 · Biomet, Inc. · Feb 1992
WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP
K914169 · Dow Corning Wright · Jan 1992
KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM
K913492 · Kirschner Medical Corp. · Dec 1991