# K981666: 2.5 MM Lactosorb Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 3, 1998 after 176 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 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
- 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
- K030425: Lorenz Resorbable Distraction System or Expander (2004), 1 descendant of its own
- K133304: RXG Distraction System (2014), 0 descendants of its own

## Indications for use
The 2.5mm LactoSorb Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to: 1. sagittal split osteotomy 2. vertical ramus osteotomy 3. inferior border osteotomy 4. subapical osteotomy 5. genioplasty

Source page: https://510kreport.com/device/K981666
Methodology: https://510kreport.com/methodology