# K033476: Modification to Hoffmann II Micro External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 20, 2004 after 78 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hoffmann II Micro External Fixation System: named in the summary without a submission number

## Most influential descendants
- K122777: NBX - Non Bridging External Fixator Hand (2013), 0 descendants of its own

## Recalls of this device
- Jul 1, 2026 · Class II · Z-2830-2026: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Jul 1, 2026 · Class II · Z-2832-2026: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Jul 1, 2026 · Class II · Z-2833-2026: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Jul 1, 2026 · Class II · Z-2827-2026: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Jul 1, 2026 · Class II · Z-2831-2026: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Jul 1, 2026 · Class II · Z-2829-2026: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Jul 1, 2026 · Class II · Z-2828-2026: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

## Indications for use
The Hoffmann® I Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffinann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Source page: https://510kreport.com/device/K033476
Methodology: https://510kreport.com/methodology