Cleared Traditional

SOLUTION SYSTEM CUP (K915216) - FDA 510(k) Clearance

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

K915216 · Depuy, Inc. · Orthopedic device
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Feb 1992
Decision
85d
Days
Class 2
Risk

K915216 is an FDA 510(k) clearance for the SOLUTION SYSTEM CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 11, 1992 after a review of 85 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 Depuy, Inc. devices

Submission Details

510(k) Number K915216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date February 11, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K915216.
PRECISION STRATA TOTAL HIP STEM
K921383 · Howmedica Corp. · Jun 1992
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
K920286 · Depuy, Inc. · Apr 1992
BIOMET NTS FEMORAL COMPONENTS
K920161 · Biomet, Inc. · Apr 1992
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K911802 · Biomet, Inc. · Jan 1992
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · Biomet, Inc. · Dec 1991
PT II DISTAL CEMENT SPACER
K914406 · Osteonics Corp. · Dec 1991