Cleared Traditional

MEDOFF SLIDING PLATE (PROPOSED NAME) (K962251) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 174
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K962251.
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537 · Synthes (Usa) · Feb 1998
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · Synthes (Usa) · Oct 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · Depuy, Inc. · Oct 1997
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
K962484 · Synthes (Usa) · Sep 1996
SYNTHES MINI EXTERNAL FIXATOR
K961350 · Synthes (Usa) · Jun 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
K961213 · Howmedica Corp. · Jun 1996