Cleared Traditional

K963614 - MONOTUBE CARBON TUBE

K963614 is an FDA 510(k) clearance for MONOTUBE CARBON TUBE, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K963614 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
57d
Days
Class 2
Risk

K963614 is an FDA 510(k) clearance for the MONOTUBE CARBON TUBE. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 57 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 Corp. devices

FDA 510(k) Submission Details - K963614

510(k) Number K963614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1996
Decision Date November 06, 1996
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K963614.
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
K981423 · Autogenesis, Inc. · May 1998
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755 · Howmedica Corp. · Jul 1997
STABLELOC II EXTERNAL FIXATOR
K965029 · Acu Med, Inc. · Feb 1997
HOFFMANN II CARBON CONNECTING ROD
K961916 · Howmedica, Inc. · Aug 1996
MONOTUBE TUBE TO RING CLAMP
K961618 · Howmedica Corp. · May 1996
TITANIUM TUBE TO TUBE CLAMP
K960782 · Synthes (Usa) · May 1996