# K041533: Synthes (Usa) [Synthes} Peri-Prosthetic Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 1, 2004 after 85 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
108 later devices descend from it; 4 cite it directly.
0 of 109 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 4.0/5.0 mm Locking Screws: named in the summary without a submission number

## Most influential descendants
- K110354: 4.5MM VA-LCP Curved Condylar Plate System (2011), 62 descendants of its own
- K120854: Synthes VA LCP Ankle Trauma System (2012), 44 descendants of its own
- K141121: Axsos 3 TI Locking Plate System (2014), 26 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own
- K162439: AxSOS 3 Ti; Stryker Plating System (2017), 24 descendants of its own

## Recalls of this device
- Apr 4, 2016 · Class II · Z-1574-2016: This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.

## Indications for use
The Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with Synthes locking plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of non-unions or malunions.

Source page: https://510kreport.com/device/K041533
Methodology: https://510kreport.com/methodology