Cleared Traditional

K945233 - PEDIATRIC OSTEOTOMY SYSTEM

K945233 is the FDA 510(k) clearance for PEDIATRIC OSTEOTOMY SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K945233 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
121d
Days
Class 2
Risk

K945233 is an FDA 510(k) clearance for the PEDIATRIC OSTEOTOMY SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 121 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 Howmedica Corp. devices

Submission Details

510(k) Number K945233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date February 01, 1995
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 271
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K945233.
INTRAMEDULLARY HIP SCREW (MODIFICATION)
K954712 · Smith & Nephew Richards, Inc. · Oct 1995
GLIDING NAIL
K951809 · Encore Orthopedics, Inc. · Jul 1995
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156 · Depuy, Inc. · May 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
K930836 · Howmedica Corp. · Jan 1995
GAMMA LOCKING NAIL - LONG LENGTH
K944883 · Howmedica Corp. · Nov 1994
GAMMA LOCKING NAIL MODIFICATION
K940286 · Howmedica, Inc. · Mar 1994