Cleared Traditional

Prelude PF Patellae (K143543) - FDA 510(k) Clearance

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

K143543 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
46d
Days
Class 2
Risk

K143543 is an FDA 510(k) clearance for the Prelude PF Patellae. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 30, 2015 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - 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

Submission Details

510(k) Number K143543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date January 30, 2015
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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 - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 13
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K143543.
MOTO PFJ System
K200122 · Medacta International S.A. · Apr 2020
Patello-Femoral Wave (Kahuna) Arthroplasty System
K181280 · Arthrosurface, Inc. · Jun 2018
Arthrex iBalance BiCompartmental Arthroplasty System
K160461 · Arthrex, Inc. · Apr 2016
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
K070695 · Zimmer, Inc. · Jun 2007
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948 · Howmedica Osteonics Corp. · Oct 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · Smith & Nephew, Inc. · May 2005