# K083573: Synthes (Usa) 3.5MM Locking Attachment Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 4, 2009 after 91 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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 1.7mm Cerclage Cable with Crimp: named in the summary without a submission number
- (no number) Synthes Universal Locking Trochanter Stabilization Plate: named in the summary without a submission number

## Most influential descendants
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws (2018), 4 descendants of its own
- K243995: Arthrex Humeral Plating System and Cerclage Button (2025), 1 descendant of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own
- K260353: Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (2026), 0 descendants of its own
- K241128: TDM Plate and Screw System (2024), 0 descendants of its own

## Indications for use
Synthes 3.5mm Locking Attachment Plate is intended.for use with Synthes LCP plates to augment the stabilization of fractures including periprosthetic fractures, and fractures in the presence of intramedullary implants in the femur, tibia and humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K083573
Methodology: https://510kreport.com/methodology