# K120903: Congruent Bone Plate System: Acu-Loc 2 Plate

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: Jul 13, 2012 after 109 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: 4 generations back to K000684 (2000). 9 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 2.

## Most influential descendants
- K233311: Acumed Wrist Plating System (2024), 3 descendants of its own
- K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (2025), 1 descendant of its own
- K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking (2013), 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
- K251732: Wrist Fracture System (2026), 0 descendants of its own

## Indications for use
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomnies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

Source page: https://510kreport.com/device/K120903
Methodology: https://510kreport.com/methodology