# K043270: Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Jan 31, 2005 after 66 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 K932330 (1996). 6 ancestors in all.
53 later devices descend from it; 5 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932330: TI-6AL-7NB Urtn, Synthes (Usa) (1996) Summary page 1.
- K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 1.
- K982601: Osteo IC Retrograde/Antegrade Femoral Nail, Osteonics Corp. (1998) Summary page 1.
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 1.
- K014220: T2 Femoral Nail System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K021744: T2 Femoral Nail, Howmedica Osteonics Corp. (2002) Summary page 1.

## Most influential descendants
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (2009), 39 descendants of its own
- K082770: Zimmer Natural Nail System Tibial Nail (2008), 35 descendants of its own
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own
- K091566: Zimmer Natural Nail System Cephalomedullary Nails (2009), 16 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0247-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Mar 23, 2009 · Not classified · Z-1261-2009: The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.

## Indications for use
Sirus intramedullary nail for femur with cap screw and corresponding locking screws * All compound and simple femoral shaft fractures * Sub-trochanteric fractures * Pseudarthrosis and delayed union Sirus intramedullary nail for femur in combination with the Sirus cervical screws * Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures Sirus intramedullary nail for tibia with cap screw and corresponding locking screws * Simple, compound first- and second-degree tibial shaft fractures * Pseudarthrosis and delayed union

Source page: https://510kreport.com/device/K043270
Methodology: https://510kreport.com/methodology