Cleared Traditional

DIMENSION-II TOTAL HIP SYSTEM (K902961) - FDA 510(k) Clearance

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

K902961 · Kirschner Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
90d
Days
Class 2
Risk

K902961 is an FDA 510(k) clearance for the DIMENSION-II TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on October 3, 1990 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 Kirschner Medical Corp. devices

Submission Details

510(k) Number K902961 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 05, 1990
Decision Date October 03, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 K902961.
OSTEONICS DRM ACETABULAR COMPONENT
K903636 · Osteonics Corp. · Oct 1990
OSTEOLOCK(TM) ACETABULAR CUP
K903362 · Howmedica Corp. · Oct 1990
FOCUS COBALT CHROMIUM TOTAL HIP
K904351 · Depuy, Inc. · Oct 1990
ACSYS PREFIX ACETABULAR CUP PROSTHESIS
K900261 · 3M Company · Sep 1990
HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE
K902436 · Zimmer, Inc. · Aug 1990
MODIFIED AML + ACETABULAR CUP SYSTEM
K902395 · Depuy, Inc. · Aug 1990