# K003018: Titan Tibial Nail

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 15, 2000 after 79 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
79 later devices descend from it; 13 cite it directly.
0 of 80 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 no predicate by number.

## Most influential descendants
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own
- K131365: T2 Tibial Nailing System (2013), 17 descendants of its own
- K113327: Hoffmann LRF (Limb Reconstruction Frame) System (2012), 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
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own

## Recalls of this device
- May 7, 2020 · Class II · Z-2383-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2380-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2375-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2374-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Apr 27, 2018 · Class II · Z-2399-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2408-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2402-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2400-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2404-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2397-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2405-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2407-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2395-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2406-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2403-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2398-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2393-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2396-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2401-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Apr 27, 2018 · Class II · Z-2394-2018: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potential
- Sep 27, 2007 · Not classified · Z-0214-2008: Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.
- Aug 4, 2003 · Not classified · Z-1295-03: The device does not have an oblong hole for dynamic locking as required.

## Indications for use
The Titan Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The Titan Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: » Open and closed tibial fractures « Pseudoarthrosis and correction osteotomy « Pathologic fractures, impending pathologic fractures, and tumor resections « Nonunion and malunion

Source page: https://510kreport.com/device/K003018
Methodology: https://510kreport.com/methodology