Cleared Special

K052089 - XR-SERIES BI-METRIC FEMORAL COMPONENTS

K052089 is an FDA 510(k) clearance for XR-SERIES BI-METRIC FEMORAL COMPONENTS, manufactured by Biomet Manufacturing, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 199-day FDA review.

K052089 · Biomet Manufacturing, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
199d
Days
Class 2
Risk

K052089 is an FDA 510(k) clearance for the XR-SERIES BI-METRIC FEMORAL COMPONENTS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 17, 2006 after a review of 199 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet Manufacturing, Inc. devices

FDA 510(k) Submission Details - K052089

510(k) Number K052089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2005
Decision Date February 17, 2006
Days to Decision 199 days
Submission Type Special
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
77d slower than avg
Panel avg: 122d · This submission: 199d
Pathway characteristics
Modification to existing cleared device.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 453
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K052089.
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581 · DePuy Orthopaedics, Inc. · May 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040 · Zimmer, Inc. · May 2006
POROUS TITANIUM ACETABULAR SHELLS
K052996 · Biomet Manufacturing Corp · Apr 2006
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
K053293 · Ortho Development Corp. · Feb 2006
VERSYS EPOCH FULLCOAT HIP PROSTHESIS
K052321 · Zimmer, Inc. · Feb 2006
DEPUY MODULAR M HEADS
K060031 · DePuy Orthopaedics, Inc. · Jan 2006