Cleared Traditional

K962251 - MEDOFF SLIDING PLATE (PROPOSED NAME)

K962251 is an FDA 510(k) clearance for MEDOFF SLIDING PLATE (PROPOSED NAME), manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K962251 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
224d
Days
Class 2
Risk

K962251 is an FDA 510(k) clearance for the MEDOFF SLIDING PLATE (PROPOSED NAME). Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 224 days - an extended review cycle.

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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K962251

510(k) Number K962251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1996
Decision Date January 22, 1997
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
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 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K962251.
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · Synthes (Usa) · Oct 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · Depuy, Inc. · Oct 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
K970290 · Ebi, L.P. · Apr 1997
MINIFIX
K964094 · Ferguson Medical · Nov 1996
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
K962484 · Synthes (Usa) · Sep 1996
ILIZAROV EXTERNAL FIXATION SYSTEM
K962808 · Smith & Nephew Richards, Inc. · Aug 1996