Cleared Traditional

K961916 - HOFFMANN II CARBON CONNECTING ROD

K961916 is the FDA 510(k) clearance for HOFFMANN II CARBON CONNECTING ROD by Howmedica, Inc.. It is a Class 2 Orthopedic device (product code JEC) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K961916 · Howmedica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
76d
Days
Class 2
Risk

K961916 is an FDA 510(k) clearance for the HOFFMANN II CARBON CONNECTING ROD. 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 August 1, 1996 after a review of 76 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 K961916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date August 01, 1996
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 K961916.
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755 · Howmedica Corp. · Jul 1997
STABLELOC II EXTERNAL FIXATOR
K965029 · Acu Med, Inc. · Feb 1997
MONOTUBE CARBON TUBE
K963614 · Howmedica Corp. · Nov 1996
MONOTUBE TUBE TO RING CLAMP
K961618 · Howmedica Corp. · May 1996
TITANIUM TUBE TO TUBE CLAMP
K960782 · Synthes (Usa) · May 1996
EZ FIX
K954838 · Biodynamic Technologies, Inc. · Jan 1996