# K974908: Synthes Sterile 2.7 MM Reconstruction Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 18, 1998 after 77 days
- Product code: HRS (Plate, Fixation, Bone)
- 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 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 2.7 mm Reconstruction Plates: named in the summary without a submission number

## Most influential descendants
- K072411: Aap Bone Plates and Screw Implants (2008), 9 descendants of its own
- K120360: Ortho Solutions Trauma Plates for Osteosysnthesis (2012), 2 descendants of its own
- K223772: PRO Plating System, Stryker Trauma Pelvic Set (Matta) (2023), 1 descendant of its own
- K202764: Ortho Solutions Plating System (2020), 1 descendant of its own
- K260054: I.T.S. PRS Phoenix II (2026), 0 descendants of its own

## Indications for use
The Synthes 2.7 mm Reconstruction Plates are intended for distal humerus fractures.

Source page: https://510kreport.com/device/K974908
Methodology: https://510kreport.com/methodology