# K024169: Macropore OS Reconstruction

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Jul 1, 2003 after 195 days
- Product code: EZX (Mesh, Surgical, Metal)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 3 cite it directly.
0 of 36 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) MacroPore OS Protective Sheet: named in the summary without a submission number
- (no number) Synthes Resorbable Meshes and Sheets: named in the summary without a submission number

## Most influential descendants
- K061206: Acute Bone Screw (2006), 33 descendants of its own
- K073556: Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos (2008), 32 descendants of its own
- 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

## Indications for use
The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: Long bones Flat bones Short bones Irregular bones Appendicular skeleton Thorax When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: Tumor resections where bone strength has not been compromised Iliac crest harvests Ribs (excluding multiple segmental defects such as those found in flail chest) This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Source page: https://510kreport.com/device/K024169
Methodology: https://510kreport.com/methodology