Cleared Abbreviated

K101472 - MULTIFIT TOTAL HIP SYSTEM

K101472 is an FDA 510(k) clearance for MULTIFIT TOTAL HIP SYSTEM, manufactured by Otis Biotech Co., Ltd.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Abbreviated 510(k) pathway after a 223-day FDA review.

K101472 · Otis Biotech Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
223d
Days
Class 2
Risk

K101472 is an FDA 510(k) clearance for the MULTIFIT TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Otis Biotech Co., Ltd. (Siheung-Si, Gyounggi-Do, KR). The FDA issued a Cleared decision on January 5, 2011 after a review of 223 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Otis Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K101472

510(k) Number K101472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2010
Decision Date January 05, 2011
Days to Decision 223 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 122d · This submission: 223d
Pathway characteristics
Standards-based clearance path.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 477
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