Cleared Traditional

K912452 - HA MCCUTCHEN SLT HIP SYSTEM

K912452 is an FDA 510(k) clearance for HA MCCUTCHEN SLT HIP SYSTEM, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K912452 · Dow Corning Wright · Orthopedic device
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Oct 1991
Decision
123d
Days
Class 2
Risk

K912452 is an FDA 510(k) clearance for the HA MCCUTCHEN SLT HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K912452

510(k) Number K912452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date October 04, 1991
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 132
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K912452.
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
K913916 · Smith & Nephew Richards, Inc. · Dec 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369 · Biomet, Inc. · Oct 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · Biomet, Inc. · Oct 1991
DIMENSION-HA HIP PROSTHESIS
K912922 · Kirschner Medical Corp. · Oct 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263 · Zimmer, Inc. · Aug 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
K911728 · Osteonics Corp. · Aug 1991