Cleared Traditional

K903938 - C FIT CUP

K903938 is an FDA 510(k) clearance for C FIT CUP, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

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

FDA 510(k) Submission Details - K903938

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
Combination Product No
PCCP Authorized No
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.

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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K903938.
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
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NEXUS ACETABULAR CUP
K905408 · Dow Corning Wright · Mar 1991
OSTEONICS(R) MPSS HIP STEM SERIES
K905275 · Osteonics Corp. · Jan 1991
BIOPRO TRINITY ACETABULAR CUP
K904207 · Biopro, Inc. · Jan 1991
OSTEONICS(R) 6011 HIP STEM SERIES
K905158 · Osteonics Corp. · Jan 1991
OSTEONICS HIP REVISION WEDGES
K905406 · Osteonics Corp. · Jan 1991