Cleared Traditional

C FIT CUP (K903938) - FDA 510(k) Clearance

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

K903938 · Orthopedic Systems, Inc. · Orthopedic device
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Jan 1991
Decision
130d
Days
Class 2
Risk

K903938 is an FDA 510(k) clearance for the C FIT CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 130 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 Orthopedic Systems, Inc. devices

Submission Details

510(k) Number K903938 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 27, 1990
Decision Date January 04, 1991
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
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 K903938.
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OSTEONICS(R) MPSS HIP STEM SERIES
K905275 · Osteonics Corp. · Jan 1991
OSTEONICS(R) 6011 HIP STEM SERIES
K905158 · Osteonics Corp. · Jan 1991
OSTEONICS HIP REVISION WEDGES
K905406 · Osteonics Corp. · Jan 1991
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K904844 · Howmedica Corp. · Dec 1990