Cleared Traditional

K971755 - HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM

K971755 is an FDA 510(k) clearance for HOFFMANN II COMPACT EXTERNAL FIXATION S..., 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 66-day FDA review.

K971755 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
66d
Days
Class 2
Risk

K971755 is an FDA 510(k) clearance for the HOFFMANN II COMPACT 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 July 17, 1997 after a review of 66 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 - K971755

510(k) Number K971755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date July 17, 1997
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 K971755.
CENTRAFIX EXTERNAL FIXATOR
K991732 · Owandar Medical, Ltd. · May 1999
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
K984442 · Hand Biomechanics Lab, Inc. · Feb 1999
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
K981423 · Autogenesis, Inc. · May 1998
STABLELOC II EXTERNAL FIXATOR
K965029 · Acu Med, Inc. · Feb 1997
MONOTUBE CARBON TUBE
K963614 · Howmedica Corp. · Nov 1996
HOFFMANN II CARBON CONNECTING ROD
K961916 · Howmedica, Inc. · Aug 1996