# K042377: Synthes Low Profile Reconstruction Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 7, 2004 after 36 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.
17 later devices descend from it; 6 cite it directly.
0 of 18 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 Reconstruction Plates: named in the summary without a submission number

## Most influential descendants
- K142836: Zimmer Plates and Screws (ZPS), Forte Screws (2014), 5 descendants of its own
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws (2018), 4 descendants of its own
- K143331: Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS (2015), 4 descendants of its own
- K221809: DePuy Synthes 3.5mm Intrapelvic Acetabular System (2022), 2 descendants of its own
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (2018), 2 descendants of its own

## Indications for use
The Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.

Source page: https://510kreport.com/device/K042377
Methodology: https://510kreport.com/methodology