# K952730: Hoffmann II External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Sep 8, 1995 after 85 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
Longest line of descent: 1 generation back to K803166 (1981). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K803166: Double Ball Joint, Howmedica Corp. (1981) Summary page 1.
- K841334: Richards Fixator System, Richards Medical Co., Inc. (1984) Summary page 1.
- (no number) Original Hoffmann® External Fixation System Components including the 5-Hole Ball Joint, 8x8 Articulating Coupling and 8x5 Articulating Coupling (Preamendment): named in the summary without a submission number
- (no number) Synthes External Fixator: named in the summary without a submission number

## Most influential descendants
- K110965: Renovis T 710 Large External Fixation System (2011), 2 descendants of its own
- K032427: Fep Fixation System and Stylo Wrist Fixation System (2003), 2 descendants of its own
- K213905: ONX Large External Fixation System (2022), 0 descendants of its own
- K171211: OIC External Fixation System (2017), 0 descendants of its own
- K070016: Blue Shark (2007), 0 descendants of its own

## Indications for use
These components are intended to be used in conjunction with Half Pins or Transfixing Pins of the Hoffmann® External Fixation System (reference K861766) for the stabilization of fractures of the tibia, femur, humerus, radius or pelvis.

Source page: https://510kreport.com/device/K952730
Methodology: https://510kreport.com/methodology