Cleared Traditional

K910986 - HOFFMANN DYNAMIC WRIST FIXATOR

K910986 is an FDA 510(k) clearance for HOFFMANN DYNAMIC WRIST FIXATOR, 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 315-day FDA review.

K910986 · Howmedica Corp. · Orthopedic device
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Jan 1992
Decision
315d
Days
Class 2
Risk

K910986 is an FDA 510(k) clearance for the HOFFMANN DYNAMIC WRIST FIXATOR. 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 January 16, 1992 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K910986

510(k) Number K910986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date January 16, 1992
Days to Decision 315 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 122d · This submission: 315d
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 K910986.
INTRAMEDULLARY HIP SCREW
K921786 · Smith & Nephew Richards, Inc. · Jul 1992
MONOTUBE EXTERNAL FIXATION SYSTEM
K910483 · Howmedica Corp. · Jul 1992
RIHARDS TITANIUM HALF PIN
K920024 · Smith & Nephew Richards, Inc. · Jan 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · Smith & Nephew Richards, Inc. · Aug 1991
AUTOGENESIS(TM) AUTOMATOR
K905514 · Advanced Biosearch Assn. · Apr 1991