# K915818: Synthes (R) Titanium Small Reconstruction Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 17, 1992 after 18 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
230 later devices descend from it; 4 cite it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990094: Kmi Wrist Fusion System (1999), 127 descendants of its own
- K991873: Kmi Wrist Fusion System (1999), 117 descendants of its own
- K021321: Wrist Fusion Plate (2002), 113 descendants of its own
- K981775: Depuy Ace Timax Calcaneal Peri-Articular Plate (1998), 112 descendants of its own
- K033639: Acumed Lower Extremity Congruent Plate System (2004), 98 descendants of its own

## Recalls of this device
- Oct 8, 2015 · Class II · Z-0236-2016: The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a
- Jan 27, 2014 · Class II · Z-1174-2014: Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.

Source page: https://510kreport.com/device/K915818
Methodology: https://510kreport.com/methodology