# K122538: Acumed Pelvic Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Nov 19, 2012 after 90 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: 9 generations back to K962616 (1996). 42 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 47 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) Summary page 2.
- K063166: I.T.S. Pelvic Reconstruction System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 1.

## Most influential descendants
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 descendants 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

## Recalls of this device
- Jan 19, 2017 · Class II · Z-1199-2017: The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V EL

## Indications for use
The Acumned Pelvic Bone Plate System includes plates, screws, and accessories designed to provide fixation during fractures, fusions, and osteotomies for the Acetabulum, sacrumn, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

Source page: https://510kreport.com/device/K122538
Methodology: https://510kreport.com/methodology