Cleared Traditional

K936124 - HOWMEDICA MONOTUBE T-CONNECTOR

K936124 is the FDA 510(k) clearance for HOWMEDICA MONOTUBE T-CONNECTOR by Howmedica, Inc.. It is a Class 2 Orthopedic device (product code JEC) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K936124 · Howmedica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
61d
Days
Class 2
Risk

K936124 is an FDA 510(k) clearance for the HOWMEDICA MONOTUBE T-CONNECTOR. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica, Inc. devices

Submission Details

510(k) Number K936124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date February 22, 1994
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 45
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K936124.
EXTERNAL FIXATOR
K943857 · Acu Med, Inc. · Jan 1995
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K922796 · Synthes (Usa) · Mar 1994
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K934698 · Howmedica Corp. · Feb 1994
OLIVE K-WIRES
K903105 · Danek Medical, Inc. · Sep 1990
ACE WIRE TENSION CLAMP
K901984 · Buckman Co., Inc. · Jun 1990
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098 · Synthes (Usa) · Apr 1990