Cleared Traditional

K051977 - SCORPIO KNEE SYSTEM TIBIAL INSERTS AND ...

K051977 is the FDA 510(k) clearance for SCORPIO KNEE SYSTEM TIBIAL INSERTS AND ... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K051977 · Howmedica Osteonics Corp. · Orthopedic device
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Oct 2005
Decision
83d
Days
Class 2
Risk

K051977 is an FDA 510(k) clearance for the SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on October 12, 2005 after a review of 83 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K051977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2005
Decision Date October 12, 2005
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 778
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K051977.
COLUMBUS (CR) TOTAL KNEE SYSTEM
K053390 · Aesculap, Inc. · Feb 2006
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
K052879 · Zimmer, Inc. · Nov 2005
PROVEN REVISION MODULAR TIBIAL TRAY
K051976 · Stelkast Company · Oct 2005
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
K051229 · Smith & Nephew, Inc. · Jul 2005
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
K050210 · Biomet, Inc. · Jul 2005
TRIATHLON KNEE SYSTEM
K051146 · Howmedica Osteonics Corp. · Jul 2005