# K071577: Biomet Microfixation Lactosorb Pectus Stabilizer

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation, Inc.
- Decided: Sep 6, 2007 after 90 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972420 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981789: Lorenz Pectus Support Bar Stabilizer, Walter Lorenz Surgical, Inc. (1998) Summary page 1.
- K972420: Lorenz Pectus Support Bar, Walter Lorenz Surgical, Inc. (1997) Summary page 1.
- K061384: Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium, Walter Lorenz Surgical, Inc. (2006) Summary page 1.

## Recalls of this device
- Mar 20, 2009 · Not classified · Z-1323-2009: This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result 

## Indications for use
The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.

Source page: https://510kreport.com/device/K071577
Methodology: https://510kreport.com/methodology