Cleared Traditional

K132873 - VANGUARD XP KNEE SYSTEM

K132873 is an FDA 510(k) clearance for VANGUARD XP KNEE SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K132873 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
89d
Days
Class 2
Risk

K132873 is an FDA 510(k) clearance for the VANGUARD XP KNEE SYSTEM. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 11, 2013 after a review of 89 days - a notably fast clearance 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: 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K132873

510(k) Number K132873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2013
Decision Date December 11, 2013
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K132873.
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
K140883 · Biomet, Inc. · Jul 2014
U2 FEMORAL COMPONENT, CR, POROUS COATED
K140075 · United Orthopedic Corp. · Jun 2014
SIGNATURE PLANNER, SIGNATURE GUIDES
K140257 · Materialise NV · Apr 2014
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624 · Stryker Orthopaedics · Nov 2013
TRIATHLON TRITANIUM TIBIAL BASEPLATE
K123486 · Stryker · May 2013
ADVANCE TOTAL KNEE SYSTEM-PATELLA
K122218 · Wrightmedicaltechnologyinc · Mar 2013