# K073556: Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos

- Pathway: 510(k) (Traditional)
- Applicant: Medxpert GmbH
- Decided: Jun 24, 2008 after 188 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
Longest line of descent: 3 generations back to K972420 (1997). 6 ancestors in all.
32 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972420: Lorenz Pectus Support Bar, Walter Lorenz Surgical, Inc. (1997) Summary page 2.
- K981789: Lorenz Pectus Support Bar Stabilizer, Walter Lorenz Surgical, Inc. (1998) Summary page 2.
- K061384: Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium, Walter Lorenz Surgical, Inc. (2006) Summary page 2.
- K061206: Acute Bone Screw, Acute Innovations, LLC (2006) Summary page 2.
- K024169: Macropore OS Reconstruction, Macropore Biosurgery, Inc. (2003) Summary page 2.

## Most influential descendants
- K133616: Matrixrib Fixation System (2014), 26 descendants of its own
- K142823: Biomet Microfixation Thoracic Fixation System (2015), 23 descendants of its own
- K151173: Biomet Microfixation RibFix Blu Thoracic Fixation System (2015), 13 descendants of its own
- K152253: Biomet Microfixation RibFix Blu Thoracic Fixation System (2016), 11 descendants of its own
- K153482: KLS Martin Thoracic Plating System (2016), 9 descendants of its own

## Indications for use
MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities. MedXpert's STRATOSTM implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum.

Source page: https://510kreport.com/device/K073556
Methodology: https://510kreport.com/methodology