# K033918: Ebi Lactosorb Graft Containment System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Aug 16, 2004 after 242 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: 2 generations back to K974017 (1998). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021164: Macropore OS Trauma, Macropore Biosurgery, Inc. (2002) Summary page 1.
- K994158: Macrosorbos Protective Sheet, Macropore Biosurgery, Inc. (2000) Summary page 1.
- K003788: Synthes Resorable Meshes and Sheets, Synthes (Usa) (2001) Summary page 2.
- K011139: Lorenz Lactosorb Panels and Fasteners, Biomet, Inc. (2001) Summary page 2.
- K984390: Lactosorb Panels and Fasteners, Biomet, Inc. (2000) Summary page 2.
- K992355: Lactosorb Trauma Plating System, Biomet, Inc. (1999) Summary page 2.

## Most influential descendants
- K073115: Orthomesh (2008), 1 descendant of its own
- K180821: TruMatch Graft Cage - Long Bone (2018), 0 descendants of its own
- K052041: Collagen Bone Healing Protective Sheet (2005), 0 descendants of its own

## Indications for use
The LactoSorb® Graft Containment 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 LactoSorb® Graft Containment System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the LactoSorh® Graft Containment 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 and ribs. When used alone (without traditional rigid fixation), the LactoSorb® Graft Containment 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 and iliac crest harvests. Tile device is not intended for use in the spine. The device is not intended for load bearing applications unless used in conjunction with traditional rigid fixation.

Source page: https://510kreport.com/device/K033918
Methodology: https://510kreport.com/methodology