# K080184: Distal Humeral Plates with Angular Stability

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Mar 26, 2008 after 61 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: 4 generations back to K000684 (2000). 16 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 1.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- K063460: Acumed Congruent Bone Plate System, Acumed, LLC (2006) Summary page 1.
- K071715: Acumed Congruent Bone Plate System, Acumed, LLC (2007) Summary page 1.
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series, Zimmer, Inc. (2004) Summary page 1.

## Most influential descendants
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K161327: Syntec Humeral Nail System (2017), 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
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1602-2026: 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. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient. Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.

Source page: https://510kreport.com/device/K080184
Methodology: https://510kreport.com/methodology