# K980944: Synthes Schuhli Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 27, 1998 after 46 days
- Product code: HTN (Washer, Bolt Nut)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Dynamic Compression Plates and screws: named in the summary without a submission number

## Indications for use
Synthes Schuhli Implant System i intended for use with Synthes long hone and small bone plates and screws, to lock the serew to the plate in order to prevent the screw from Joosening and backing out of the bone. Specifically, they are used in osteuporotic bone for unicortical (of the near cortex) or bicorticul [ixation in cases of trauma, tumor, or infection. and as fixed angle devices (where the angle between two supporting members is fixod).

Source page: https://510kreport.com/device/K980944
Methodology: https://510kreport.com/methodology