Cleared Traditional

K952730 - HOFFMANN II EXTERNAL FIXATION SYSTEM

K952730 is the FDA 510(k) clearance for HOFFMANN II EXTERNAL FIXATION SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JEC) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K952730 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
85d
Days
Class 2
Risk

K952730 is an FDA 510(k) clearance for the HOFFMANN II EXTERNAL FIXATION SYSTEM. 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 September 8, 1995 after a review of 85 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

Submission Details

510(k) Number K952730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1995
Decision Date September 08, 1995
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 43
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K952730.
TITANIUM TUBE TO TUBE CLAMP
K960782 · Synthes (Usa) · May 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · Howmedica Corp. · Jan 1996
EXTERNAL FIXATOR
K952330 · Acu Med, Inc. · Oct 1995
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K944092 · Orthofix Srl · Apr 1995
EXTERNAL FIXATOR
K943857 · Acu Med, Inc. · Jan 1995
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994