Cleared Traditional

OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES (K951956) - FDA 510(k) Clearance

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

K951956 · Osteonics Corp. · Orthopedic device
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Aug 1995
Decision
107d
Days
Class 2
Risk

K951956 is an FDA 510(k) clearance for the OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES. 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 August 11, 1995 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonics Corp. devices

Submission Details

510(k) Number K951956 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 26, 1995
Decision Date August 11, 1995
Days to Decision 107 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K951956.
DARWIN KNEE SYSTEM (TC3)
K952830 · Johnson & Johnson Professionals, Inc. · Jan 1996
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
K954138 · Howmedica Corp. · Nov 1995
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
K940861 · Howmedica Corp. · Sep 1995
DURACON BASEPLATES
K936008 · Howmedica Corp. · Aug 1995
DEPUY AMK CO-CR FINNED TIBIAL TRAY
K951027 · Depuy, Inc. · Jul 1995
CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
K946150 · Zimmer, Inc. · Jul 1995