Cleared Traditional

K120030 - TAPERLOC COMPLETE SIZE 4MM AND XR 123

K120030 is an FDA 510(k) clearance for TAPERLOC COMPLETE SIZE 4MM AND XR 123, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K120030 · Biomet Manufacturing Corp · Orthopedic device
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Aug 2012
Decision
226d
Days
Class 2
Risk

K120030 is an FDA 510(k) clearance for the TAPERLOC COMPLETE SIZE 4MM AND XR 123. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on August 17, 2012 after a review of 226 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. 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 Manufacturing Corp devices

FDA 510(k) Submission Details - K120030

510(k) Number K120030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2012
Decision Date August 17, 2012
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K120030.
TAPERSET HIP SMALL STEMS
K121935 · Consensus Orthopedics, Inc. · Sep 2012
IOI TOTAL HIP
K121034 · Iconacy Orthopedic Implants, LLC · Sep 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · Smith & Nephew, Inc. · Aug 2012
HIP SYSTEMS
K121308 · Howmedica Osteonics Corp. · Jul 2012
U2 ACETABULAR CUP, PLASMA SPRAY
K121777 · United Orthopedic Corp. · Jul 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
K121024 · Encore Medical, L.P. · Jun 2012