# K051412: Humeral Head Plate with Angular Stability

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Jul 11, 2005 after 41 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: 2 generations back to K983853 (1998). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 1.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 1.
- K042059: Shoulder Fixation System, Hand Innovations, Inc. (2004) Summary page 1.
- K041965: Arthrex Humeral Fracture Plates and Screws, Arthrex, Inc. (2004) Summary page 1.
- K983853: Depuy Ace Timax Meta Plate, Depuy Ace Medical Co. (1998) Summary page 1.
- K955472: Ace Humerus & Radius Plates, Ace Medical Co. (1996) Summary page 1.

## Most influential descendants
- 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
- K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (2023), 0 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1594-2026: 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. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder. Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K051412
Methodology: https://510kreport.com/methodology