# K093928: Synthes 3.5MM Quadrilateral Surface Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 29, 2010 after 97 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; 3 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 One-Third Tubular Plates: named in the summary without a submission number

## Most influential descendants
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 descendants 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
- K260054: I.T.S. PRS Phoenix II (2026), 0 descendants of its own
- K241666: EVOS Pelvic and Acetabular System (2025), 0 descendants of its own
- K201229: Intai Anatomic Locking Plate and Screw System (2022), 0 descendants of its own

## Indications for use
Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.

Source page: https://510kreport.com/device/K093928
Methodology: https://510kreport.com/methodology