# K042409: Modular Arthrodesis Nail

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 2, 2004 after 90 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982953 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993603: Wichita Fusion Nail Fully Threaded Self-Tapping Screw, Howmedica Osteonics Corp. (1999) Summary page 1.
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 1.
- K020384: T2 Arthrodesis Nail System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.

## Recalls of this device
- Nov 29, 2022 · Class II · Z-1036-2023: Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
- Apr 3, 2018 · Class II · Z-1522-2018: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.

## Indications for use
The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee. Indications include: 1. Treatment of patients who are not candidates for total knee arthroplasty 2. Irretrievably failed total knee arthroplasty 3. Limb salvage in oncology surgery 4. Trauma 5. Any other condition where there is little soft tissue or bony tissue available for support, and arthrodesis is the treatment of choice. These devices are intended for cemented use only.

Source page: https://510kreport.com/device/K042409
Methodology: https://510kreport.com/methodology