# K021522: Lorenz 1.5 X 4 MM Lactosorb Tap Free Screw

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: May 21, 2002 after 11 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
Longest line of descent: 1 generation back to K971870 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 2.
- K002423: Lactosorb Push Screw, Biomet, Inc. (2000) Summary page 2.

## Indications for use
The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures. A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: Comminuted fractures of the naso-ethmoidal infraorbital areas Comminuted fractures of the frontal sinus wall Pediatric midface or craniofacial trauma LeFort (I, II, III) fractures Orbital floor fractures Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones. B. General Indication: reconstructive procedures of the midface or craniofacial skeleton Specific Indications: Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.) LeFort (I, II, III) osteotomies Tumor reconstruction in midface or craniofacial procedures Bone graft procedures in the midface or craniofacial skeleton Pediatric reconstructive procedures Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones Craniotomy flap fixation This system is not designed for use in the mandible and/or full load bearing procedures.

Source page: https://510kreport.com/device/K021522
Methodology: https://510kreport.com/methodology