# K983641: Holland Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 4, 1998 after 49 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 3 cite it directly.
0 of 32 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 its predicate without a number.
- (no number) Synthes Titanium Unreamed Femoral Nail: named in the summary without a submission number
- (no number) Alta® Femoral Nail: named in the summary without a submission number

## Most influential descendants
- K072161: Biomet Femoral Locking Nail System (2007), 22 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K050118: Ebi Trochanteric Nail System (2005), 7 descendants of its own
- K120148: Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw (2012), 6 descendants of its own
- K083726: Pedinail Intramedullary Nailing System (2009), 6 descendants of its own

## Indications for use
1) fresh fractures of the femur to include; non-comminuted midshaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. 2) osteotomy and reconstructive procedures following tumor resection. 3) revision procedures where other treatments or devices have failed. 4) arthrodesis.

Source page: https://510kreport.com/device/K983641
Methodology: https://510kreport.com/methodology