# K963030: Leibinger Imf Screw

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: Apr 11, 1997 after 249 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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 K820944 (1982). 3 ancestors in all.
25 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820944: Dental Arch Bar, Unisplint Corp. (1982) Summary page 3.
- K912932: Synthes Maxillofacial Titanium Micro Set, Synthes (Usa) (1991) Summary page 3.
- K963740: Leibinger - Luhr Small Mandibular Bone Screws, Howmedica Leibinger, Inc. (1996). Cleared while this submission was under review Summary page 3.
- (no number) Synthes Minihook and Cortical Screw: named in the summary without a submission number

## Most influential descendants
- K050535: Stryker MMF Screw (2005), 11 descendants of its own
- K122313: Stryker Universal Smartlock Hybrid MMF System (2012), 10 descendants of its own
- K983728: Lorenz Imf Screw (1999), 9 descendants of its own
- K980760: KLS-Martin MMF Screw (1999), 8 descendants of its own
- K040983: Lorenz Self-Drilling Imf Screw (2004), 7 descendants of its own

Source page: https://510kreport.com/device/K963030
Methodology: https://510kreport.com/methodology