Cleared Traditional

K881288 - CORIN MODULAR MOORE STEM

K881288 is an FDA 510(k) clearance for CORIN MODULAR MOORE STEM, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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

FDA 510(k) Submission Details - K881288

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
Combination Product No
PCCP Authorized No
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.

LWJ Device Classification - Class 2, Special Controls

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 57
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
S-ROM SUPERCUP ACETABULAR CUP
K870088 · Joint Medical Products Corp. · Apr 1988
TI-FIT TOTAL HIP SYSTEM
K873797 · Richards Medical Co., Inc. · Nov 1987
MICRO-STRUCTURED HS2P HIP STEMS
K833970 · Osteonics Corp. · Jan 1984