# K971755: Hoffmann II Compact External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jul 17, 1997 after 66 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 6 cite it directly.
0 of 11 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) Original Hoffmann® External Fixation System: named in the summary without a submission number
- (no number) Hoffmann® II External Fixation System: named in the summary without a submission number

## Most influential descendants
- K012648: Reprocessed Howmedica External Fixation Devices (2002), 2 descendants of its own
- K141912: Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon (2014), 1 descendant of its own
- K071628: Stryker External Fixation System (2007), 1 descendant of its own
- K052062: Alliance Medical Corporation Reprocessed External Fixation Devices (2005), 1 descendant of its own
- K232897: Arthrex Small External Fixation System (2023), 0 descendants of its own

## Recalls of this device
- Aug 17, 2005 · Not classified · Z-2080-2008: Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.

## Indications for use
The Hoffmann® II Compact External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® 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 the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting. And other means of internal fixation.

Source page: https://510kreport.com/device/K971755
Methodology: https://510kreport.com/methodology