Cleared Traditional

K912162 - INTRAMEDULLARY HIP SCREW

K912162 is the FDA 510(k) clearance for INTRAMEDULLARY HIP SCREW by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K912162 · Smith & Nephew Richards, Inc. · Orthopedic device
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Aug 1991
Decision
90d
Days
Class 2
Risk

K912162 is an FDA 510(k) clearance for the INTRAMEDULLARY HIP SCREW, MODIFICATION. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on August 14, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K912162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date August 14, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K912162.
RIHARDS TITANIUM HALF PIN
K920024 · Smith & Nephew Richards, Inc. · Jan 1992
HOFFMANN DYNAMIC WRIST FIXATOR
K910986 · Howmedica Corp. · Jan 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE
K901234 · Kirschner Medical Corp. · Oct 1990
SIDE PLATE
K903246 · Onyx Medical Corp. · Jul 1990
BLADE PLATE
K903250 · Onyx Medical Corp. · Jul 1990