# K131132: Pelvis II Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: May 31, 2013 after 38 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: 1 generation back to K001614 (2000). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001614: Stryker Trauma Pelvic Set, Howmedica Osteonics Corp. (2000)

## Most influential descendants
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 descendants of its own
- K223772: PRO Plating System, Stryker Trauma Pelvic Set (Matta) (2023), 1 descendant of its own
- 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

## Indications for use
Indications for the Pelvis 11 implant System will include fractures of the following regions of the pelvis ring: * Anterior Column * Anterior Column combined with posterior hemi-transverse * Quadrilateral Surface

Source page: https://510kreport.com/device/K131132
Methodology: https://510kreport.com/methodology