# K994158: Macrosorbos Protective Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Jul 24, 2000 after 228 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: 1 generation back to K974017 (1998). 1 ancestor in all.
35 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974017: Timesh System, Sofamor Danek USA,Inc. (1998) Summary page 3.

## 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
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- K193660: OSSIOfiber™ Compression Screws (2020), 6 descendants of its own

## Indications for use
The MacroPoreOS Protective Sheet 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 MacroPoreOS Protective sheet is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPoreOS Protective Sheet 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 MacroPoreOS Protective Sheet 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 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/K994158
Methodology: https://510kreport.com/methodology