# K061973: Synthes 3.5MM Spring Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 11, 2006 after 61 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 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 One-Third Tubular LCP Plates, with collar: 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
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 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
- K260958: I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (2026), 0 descendants of its own

## Indications for use
The Synthes 3.5mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.

Source page: https://510kreport.com/device/K061973
Methodology: https://510kreport.com/methodology