# K260054: I.T.S. PRS Phoenix II

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. GmbH
- Decided: Apr 24, 2026 after 106 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 176 ancestors in all.
No later device cites it as a predicate yet.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix), I.T.S. GmbH (2022) Summary page 5.
- K063166: I.T.S. Pelvic Reconstruction System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 5.
- K223772: PRO Plating System, Stryker Trauma Pelvic Set (Matta), Stryker GmbH (2023) Summary page 5.
- K221809: DePuy Synthes 3.5mm Intrapelvic Acetabular System, DePuy Synthes (2022) Summary page 5.
- K122538: Acumed Pelvic Bone Plate System, Acumed, LLC (2012) Summary page 5.

## Indications for use
The I.T.S. PRS Phoenix II is indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient. Indications for use of the I.T.S. PRS Phoenix II include: • Symphyseal Disruptions & Parasymphyseal Fractures • Disruptions of the Sacroiliac Joint • Fractures involving the Anterior Column of the Acetabulum • Fractures involving the Quadrilateral Surface • Fractures involving the Posterior Wall • Fractures involving the Posterior Column • Dorsal neutralization plating for Posterior Pelvic Ring Fractures • Fractures of the Acetabulum, Fractures of the Pelvic Ring, Fractures of the Ilium • Fracture Revision surgery of pseudoarthrosis, non-unions and mal-unions The I.T.S. PRS Phoenix II System is not intended for spinal use.

Source page: https://510kreport.com/device/K260054
Methodology: https://510kreport.com/methodology