# K980927: Lactosorb Panels and Fasteners

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 5, 1998 after 86 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K983360: Macropore Protective Sheet (1999), 6 descendants of its own
- K011569: Biosorbfx O/M 2.0/2/4 System (2002), 5 descendants of its own
- K061881: Osteotrans -MX Bioabsorbable Bone Fixation System (2007), 3 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K121606: Resorb-X G (2013), 0 descendants of its own

## Recalls of this device
- Mar 19, 2008 · Not classified · Z-1872-2008: The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and 

## Indications for use
The LactoSorb Panels and Fasteners are used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.

Source page: https://510kreport.com/device/K980927
Methodology: https://510kreport.com/methodology