Cleared Traditional

K945233 - PEDIATRIC OSTEOTOMY SYSTEM

K945233 is an FDA 510(k) clearance for PEDIATRIC OSTEOTOMY SYSTEM, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K945233

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.

KTT Device Classification - Class 2, Special Controls

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 358
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K945233.
GLIDING NAIL
K951809 · Encore Orthopedics, Inc. · Jul 1995
EBI SMALL EXTERNAL FIXATOR (S/E/F/)
K951357 · Electro-Biology, Inc. · Jun 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
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
K926417 · Alphatec Mfg., Inc. · Sep 1994