# K050852: Claviculaplate with Angular Stablity Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Jun 22, 2005 after 79 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: 3 generations back to K000684 (2000). 8 ancestors in all.
38 later devices descend from it; 4 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)
- K011334: Synthes Curved Reconstruction Plate, Synthes (Usa) (2001)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- (no number) Synthes Hook Plate: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K010335: Slendertone Flex, Model, 512, Bio-Medical Research, Ltd. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K060156: Straight Plate with Angular Stability & Screw System (2006), 27 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own
- K100944: Clavicle Locking Plate System (2010), 9 descendants of its own
- K063166: I.T.S. Pelvic Reconstruction System (2006), 9 descendants of its own
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), 8 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1593-2026: 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. Claviculatplate with Angular Stability is a titanium implant fracture fixation system for repairing fractures located from the middle third to the distal third of the clavicle. Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the clavicle. Other indications include corrective osteotomy and open and closed fractures. The system is not intended for spinal use.

Source page: https://510kreport.com/device/K050852
Methodology: https://510kreport.com/methodology