# K063166: I.T.S. Pelvic Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Dec 22, 2006 after 65 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962616 (1996). 41 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031573: Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate, Synthes (Usa) (2003) Summary page 1.
- K001614: Stryker Trauma Pelvic Set, Howmedica Osteonics Corp. (2000)
- K001720: Synthes Sacral Bar System, Synthes (Usa) (2000) Summary page 1.
- K051642: FR.O.H. Calcaneus Repair System, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 1.
- K013044: Synthes 3.9 MM Pelvic Screws, Synthes (Usa) (2001) Summary page 1.
- K060156: Straight Plate with Angular Stability & Screw System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 1.
- (no number) Zimmer Pelvic Reconstruction Set: named in the summary without a submission number

## Most influential descendants
- K122538: Acumed Pelvic Bone Plate System (2012), 4 descendants of its own
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) (2026), 0 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1600-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
- May 9, 2019 · Class II · Z-1718-2019: The titanium implant has the wrong article number laser marked on it.

## Indications for use
The intended use of the ITS. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems. Indications for use of the ITS. PRS Low Profile - Multiple Type - Pelvic Plating System include: 1) Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring, 2) Revision surgery of pseoduarthroses, non-unions and mal-unions, 3) lio-Iliac distance osteosynthesis, 4) Osteotomies, 5) Arthrodesis, 6) Sacroiliac joint dislocations, and 7) Symphysis pubis disruptures Indications far use of the I.T.S. PRS Sacral Rod System include: 1) Fixation of fractures of the posterior pelvis, 2) Fixation of fractures of the posterior iliac spine, 3) Fixation of fractures of the posterior inferior iliac spine, 4) Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries, 5) Fixation of sacral fractures, and 6) Fracture dislocations of the sacro-iliac joint Indications for us of ethe ITS. PRS 7.3mm Cannulated SIJ Traction Screw & Washer includefaure f of pelvi fractures where indicated and for periacetabular osteotomies. The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.

Source page: https://510kreport.com/device/K063166
Methodology: https://510kreport.com/methodology