Cleared Traditional

K033971 - SCORPIO TOTAL KNEE SYSTEM WITH PERI-APA...

K033971 is the FDA 510(k) clearance for SCORPIO TOTAL KNEE SYSTEM WITH PERI-APA... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K033971 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
158d
Days
Class 2
Risk

K033971 is an FDA 510(k) clearance for the SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 158 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K033971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date May 28, 2004
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 123
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K033971.
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS
K041872 · Biomet Manufacturing Corp · Sep 2004
3DKNEE POROUS COATED FEMORAL COMPONENT
K032905 · Encore Orthopedics, Inc. · Jul 2004
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
K033489 · Biomet, Inc. · Jun 2004
SCORPIO TOTAL KNEE SYSTEM
K033972 · Howmedica Osteonics Corp. · Apr 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
K032108 · Aesculap, Inc. · Jan 2004
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · Smith & Nephew, Inc. · Oct 2003