# K102885: Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II EX

- Pathway: 510(k) (Special)
- Applicant: Stryker Corp.
- Decided: Jan 14, 2011 after 106 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.
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 MRI System: named in the summary without a submission number

## Most influential descendants
- K163028: Medline ReNewal Reprocessed Stryker External Fixation Devices (2016), 0 descendants of its own

## Recalls of this device
- Nov 21, 2019 · Class II · Z-0781-2020: Pin To Rod Coupling could not clamp the pin and rod as intended

## Indications for use
The Hoffmann II External Fixation System 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 mecans of internal fixation. The indications for use of metallic external fixation devices include: * Bone fracture fixation * Osteotomy * Arthrodesis * Correction of deformity * Revision procedures where other treatments or devices have been unsuccessful * Bone reconstruction procedures

Source page: https://510kreport.com/device/K102885
Methodology: https://510kreport.com/methodology