# K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. GmbH
- Decided: Aug 31, 2022 after 520 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962616 (1996). 167 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063166: I.T.S. Pelvic Reconstruction System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 5.
- K131722: I.T.S. Extremity Fixation Systems, I.T.S. GmbH (2013) Summary page 5.
- K001614: Stryker Trauma Pelvic Set, Howmedica Osteonics Corp. (2000) Summary page 5.
- K131132: Pelvis II Implant System, Stryker Trauma AG (2013) Summary page 5.
- K031573: Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate, Synthes (Usa) (2003) Summary page 5.
- K093928: Synthes 3.5MM Quadrilateral Surface Plates, Synthes (Usa) (2010) Summary page 5.
- K122538: Acumed Pelvic Bone Plate System, Acumed, LLC (2012) Summary page 5.
- K061973: Synthes 3.5MM Spring Plate, Synthes (Usa) (2006) Summary page 5.

## Most influential descendants
- K260958: I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (2026), 0 descendants of its own
- K260054: I.T.S. PRS Phoenix II (2026), 0 descendants of its own
- K241666: EVOS Pelvic and Acetabular System (2025), 0 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1608-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

## Indications for use
The I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient. Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include: » Fractures of the acetabulum * Fractures of the pelvic ring * Fractures of the quadrilateral surface * Fractures of the sympyhsis * Fractures of the ilium * Fractures of the SIJ * [lio-iliac distance osteosynthesis » Symphysis pubis disruptions, osteotomies, arthrodesis and sacroiliac joint dislocations * Revision surgery of pseudoarthroses, non-unions and mal-unions The I.T.S. PRS RX System is not intended for spinal use. Indications for use of the I.T.S. Pelvic Reconstruction System (PRS Phoenix) include: * Fractures involving the Posterior Wall & Posterior Column * Fractures involving the Anterior Column of the Acetabulum * Fractures involving the Quadrilateral Surface » Symphyseal Disruptions & Para-symphyseal Fractures * Fractures of the ilium * Fractures of the SIJ * Dorsal neutralization plating for posterior pelvic ring fractures » Osteotomies, arthrodesis and sacroiliac joint dislocations * Revision surgery of pseudoarthroses, non-unions and mal-unions The I.T.S. PRS Phoenix System is not intended for spinal use. Indications for use of the I.T.S. Infra-acetabular screw placement include: * Fractures involving the anterior column, e.g. anterior column, anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures The I.T.S. Infra-acetabular screw is not intended for spinal use. Indications for use of the I.T.S. 8.5mm Cannulated Screws & Washer include: * Pelvic fractures The I.T.S. 8.5mm Cannulated Screws & Washer are not intended for spinal use.

Source page: https://510kreport.com/device/K210935
Methodology: https://510kreport.com/methodology