# K021164: Macropore OS Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Jul 1, 2002 after 81 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.
26 later devices descend from it; 2 cite it directly.
0 of 27 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
- (no number) MacroPore OS Spine: named in the summary without a submission number

## Most influential descendants
- K031961: Inion Otps Biodegradable Mesh Plating System (2004), 21 descendants of its own
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (2013), 17 descendants of its own
- K160304: OsteoBullet Compression Screw (2016), 8 descendants of its own
- K193660: OSSIOfiber™ Compression Screws (2020), 6 descendants of its own
- K221193: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (2022), 4 descendants of its own

## Indications for use
The MacroPore OS Trauma 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 MacroPore OS Trauma System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPore OS Trauma System is intended to maintain the relative position 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 Trauma 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 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/K021164
Methodology: https://510kreport.com/methodology