# K163028: Medline ReNewal Reprocessed Stryker External Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Dec 28, 2016 after 58 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 K102885 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102885: Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II EX, Stryker Corp. (2011) Summary page 7.

## Indications for use
The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional, Hoffmann II MR Conditional, Hoffmann 11, Hoffmann 11 Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixation The indications for use of external fixation devices include: * bone fracture fixation; * osteotomy; « arthrodesis; » correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and * bone reconstruction procedures.

Source page: https://510kreport.com/device/K163028
Methodology: https://510kreport.com/methodology