Cleared Traditional

K102125 - PATIENT-SPECIFIC VANGUARD FEMORAL COMPO...

K102125 is the FDA 510(k) clearance for PATIENT-SPECIFIC VANGUARD FEMORAL COMPO... by Biomet, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K102125 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
209d
Days
Class 2
Risk

K102125 is an FDA 510(k) clearance for the PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 209 days - an extended review 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: 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 Biomet, Inc. devices

Submission Details

510(k) Number K102125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date February 23, 2011
Days to Decision 209 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
87d slower than avg
Panel avg: 122d · This submission: 209d
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 786
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K102125.
GMK REVISION KNEE SC LINERS
K103170 · Medacta International S.A. · Mar 2011
VANGUARD REMOVABLE MOLDED POLY TIBIA
K102580 · Biomet Manufacturing Corp · Mar 2011
VANGUARD ASYMMETRICAL PATELLAR COMPONENT
K110362 · Biomet Manufacturing Corp · Feb 2011
SIGNATURE PLANNER
K102795 · Materialise NV · Feb 2011
EVOLUTION MP TOTAL KNEE SYSTEM
K102380 · Wrightmedicaltechnologyinc · Jan 2011
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K103117 · Conformis, Inc. · Jan 2011