Cleared Traditional

K903116 - RM ISOELASTIC BEVELLED ACETABULAR CUP

K903116 is an FDA 510(k) clearance for RM ISOELASTIC BEVELLED ACETABULAR CUP, manufactured by Robert Mathys Co.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K903116 · Robert Mathys Co. · Orthopedic device
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Oct 1990
Decision
99d
Days
Class 2
Risk

K903116 is an FDA 510(k) clearance for the RM ISOELASTIC BEVELLED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Robert Mathys Co. (Malvern, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 99 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.

FDA 510(k) Submission Details - K903116

510(k) Number K903116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1990
Decision Date October 23, 1990
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
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 540
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K903116.
VSP HIP STEM
K903957 · Turnkey Intergration USA, Inc. · Nov 1990
PERFECTA TOTAL HIP SYSTEM
K903635 · Orthomet, Inc. · Nov 1990
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
DIMENSION-II TOTAL HIP SYSTEM
K902961 · Kirschner Medical Corp. · Oct 1990
K903116 · RM ISOELASTIC BEVELLED ACETABULAR CUP
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