# K984390: Lactosorb Panels and Fasteners

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 7, 2000 after 608 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 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 no predicate by number.

## Most influential descendants
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- K033918: Ebi Lactosorb Graft Containment System (2004), 3 descendants of its own
- K073115: Orthomesh (2008), 1 descendant of its own
- K063709: TS-Bone Hip Tool (2007), 1 descendant of its own
- K040850: Tsy Shoulder Plate Implant (2004), 1 descendant of its own

## Indications for use
The LactoSorb® Panels and Fasteners are used in maintaining the position of bony fragments or morselized bone graft in Iliac crest autograft procedures. This product is not intended for use in the spine or joint space. This product is not intended for pelvic fracture fixation.

Source page: https://510kreport.com/device/K984390
Methodology: https://510kreport.com/methodology