# K003281: Lactosorb Rapidflap

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 7, 2001 after 292 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130309: Rapidflap LS Cranial Flap Fixation System (2013), 1 descendant of its own
- K073115: Orthomesh (2008), 1 descendant of its own
- K221606: Absorbable Cranial Flap Fixation System (2023), 0 descendants of its own
- K180821: TruMatch Graft Cage - Long Bone (2018), 0 descendants of its own

## Recalls of this device
- Apr 5, 2018 · Class II · Z-1705-2018: The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product wher

Source page: https://510kreport.com/device/K003281
Methodology: https://510kreport.com/methodology