# K070946: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 6, 2007 after 63 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
No predicates in its family tree.
132 later devices descend from it; 7 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Locking Distal Radius Plating System: named in the summary without a submission number
- (no number) Synthes Small Fragment Dynamic Compression Locking System: named in the summary without a submission number

## Most influential descendants
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates (2010), 80 descendants of its own
- K142906: APTUS Wrist 2.5 System (2015), 59 descendants of its own
- K112455: Aiming Blocks for Variax Distal Radius Plates (2011), 56 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- K132502: Variax 2 System (2013), 21 descendants of its own

## Recalls of this device
- May 2, 2016 · Class II · Z-1949-2016: Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-

## Indications for use
Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for fractures, osteotomies, and non-unions of the radius and other small bones.

Source page: https://510kreport.com/device/K070946
Methodology: https://510kreport.com/methodology