# K052483: Synthes (Usa) Spherical Washers

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 4, 2005 after 56 days
- Product code: NDG (Washer, Bolt, Nut, Non-Spinal, Metallic)
- 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
No predicates in its family tree.
196 later devices descend from it; 9 cite it directly.
1 of 197 devices in its family (counting itself) has 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 13.0 mm Washer: named in the summary without a submission number

## Most influential descendants
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Indications for use
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments. In addition. the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).

Source page: https://510kreport.com/device/K052483
Methodology: https://510kreport.com/methodology