# K031573: Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 6, 2003 after 17 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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.
24 later devices descend from it; 6 cite it directly.
0 of 25 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 3.5 mm LCP Reconstruction Plate: named in the summary without a submission number

## Most influential descendants
- K113733: Small and Large Fragments Osteosynthesis System Neofix (2012), 11 descendants of its own
- K063166: I.T.S. Pelvic Reconstruction System (2006), 9 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K122538: Acumed Pelvic Bone Plate System (2012), 4 descendants of its own

## Indications for use
Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

Source page: https://510kreport.com/device/K031573
Methodology: https://510kreport.com/methodology