# K961916: Hoffmann II Carbon Connecting Rod

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Aug 1, 1996 after 76 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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® Stainless Steel Rods: named in the summary without a submission number
- (no number) Hoffmann® II Aluminum Rods: named in the summary without a submission number
- (no number) Synthes Carbon Fiber Rods: named in the summary without a submission number
- (no number) Carbon Tubes of The Monotube External Fixation System: named in the summary without a submission number

## Most influential descendants
- K080408: External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp, 9.5MM Rod (2008), 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
- K232897: Arthrex Small External Fixation System (2023), 0 descendants of its own
- K072764: KLS Martin Xternal Fixator (2007), 0 descendants of its own

## Indications for use
This submission describes a Carbon Fiber Composite Connecting Rod intended to be used with the components of the Hoffmann® II External Fixation System for the stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments.

Source page: https://510kreport.com/device/K961916
Methodology: https://510kreport.com/methodology