# K994364: Synthes Button Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 15, 2000 after 79 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Arthrex's Bio-Button: named in the summary without a submission number

## Most influential descendants
- K102539: Icuff Repair Plate, Right; Cuff Repair Plate. Left; Anchor Bolt, 10MM Through 50MM (2011), 0 descendants of its own

## Recalls of this device
- May 31, 2016 · Class II · Z-2138-2016: DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.

## Indications for use
Synthes Button Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

Source page: https://510kreport.com/device/K994364
Methodology: https://510kreport.com/methodology