Cleared Traditional

CORIN MODULAR MOORE STEM (K881288) - FDA 510(k) Clearance

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

K881288 · Orthopedic Systems, Inc. · Orthopedic device
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Jun 1988
Decision
93d
Days
Class 2
Risk

K881288 is an FDA 510(k) clearance for the CORIN MODULAR MOORE STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on June 29, 1988 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K881288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date June 29, 1988
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 25
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K881288.
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661 · Depuy, Inc. · Feb 1989
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · Osteonics Corp. · Oct 1988
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983 · Howmedica Corp. · Oct 1988
MICRO-STRUCTURED HS2P HIP STEMS
K833970 · Osteonics Corp. · Jan 1984