Cleared Traditional

K011774 - R120 MODULAR TOTAL HIP SYSTEM

K011774 is an FDA 510(k) clearance for R120 MODULAR TOTAL HIP SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011774 · Osteoimplant Technology, Inc. · Orthopedic device
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Sep 2001
Decision
90d
Days
Class 2
Risk

K011774 is an FDA 510(k) clearance for the R120 MODULAR TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on September 5, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K011774

510(k) Number K011774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2001
Decision Date September 05, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 483
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K011774.
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · DePuy Orthopaedics, Inc. · Dec 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · DePuy Orthopaedics, Inc. · Nov 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · Sulzer Orthopedics, Inc. · Oct 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · Exactech, Inc. · Aug 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · Biomet, Inc. · Jul 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455 · Biomet, Inc. · Jul 2001