Cleared Traditional

R120 MODULAR TOTAL HIP SYSTEM (K021822) - FDA 510(k) Clearance

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

K021822 · Osteoimplant Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
49d
Days
Class 2
Risk

K021822 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 July 23, 2002 after a review of 49 days - a notably fast clearance cycle.

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: 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 Osteoimplant Technology, Inc. devices

Submission Details

510(k) Number K021822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2002
Decision Date July 23, 2002
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K021822.
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · Smith & Nephew, Inc. · Oct 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077 · Howmedica Osteonics Corp. · Jul 2002
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K022094 · Biomet, Inc. · Jul 2002
OSS LES PROXIMAL FEMORAL COMPONENT
K021380 · Biomet, Inc. · May 2002
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K021310 · Howmedica Osteonics Corp. · May 2002
SUPER EON PLUS FEMORAL STEMS
K020989 · Howmedica Osteonics Corp. · Apr 2002