Cleared Traditional

K930836 - HOWMEDICA MONO-TUBE(TM) EXTERNAL FIXATO...

K930836 is the FDA 510(k) clearance for HOWMEDICA MONO-TUBE(TM) EXTERNAL FIXATO... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 700-day FDA review.

K930836 · Howmedica Corp. · Orthopedic device
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Jan 1995
Decision
700d
Days
Class 2
Risk

K930836 is an FDA 510(k) clearance for the HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR 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 January 18, 1995 after a review of 700 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K930836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date January 18, 1995
Days to Decision 700 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
578d slower than avg
Panel avg: 122d · This submission: 700d
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 K930836.
GLIDING NAIL
K951809 · Encore Orthopedics, Inc. · Jul 1995
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156 · Depuy, Inc. · May 1995
PEDIATRIC OSTEOTOMY SYSTEM
K945233 · Howmedica Corp. · Feb 1995
GAMMA LOCKING NAIL - LONG LENGTH
K944883 · Howmedica Corp. · Nov 1994
GAMMA LOCKING NAIL MODIFICATION
K940286 · Howmedica, Inc. · Mar 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
K925460 · Synthes (Usa) · Mar 1994