# K011334: Synthes Curved Reconstruction Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 27, 2001 after 86 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.
798 later devices descend from it; 5 cite it directly.
1 of 799 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012655: Congruent Bone Plate System (2001), 792 descendants of its own
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 descendants of its own
- K071563: Peri-Loc Periarticular Locked Plating System (2007), 495 descendants of its own
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K021626: Hallu Plates (2002), 280 descendants of its own

Source page: https://510kreport.com/device/K011334
Methodology: https://510kreport.com/methodology