T2 Recon Nail System
by Howmedica Osteonics Corp. 2 variants
510(k) K032898
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032898 | Date9 Oct 2003 | StatusActive |
Recalls
-
- Terminated Z-0060-06
The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HSB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The T2 Recon Nail System is an intramedullary fixation device classified under Intramedullary fixation rod (21 CFR 888.3020). It is designed for internal fixation of femoral fractures, providing stable alignment through an intramedullary nail with modular locking components, including femoral nails, locking screws, set screws, end caps, and lag screws. The system offers both retrograde and antegrade femoral locking options to address various fracture patterns and anatomical considerations. Its modular design allows for customisation to suit different clinical scenarios while maintaining structural integrity during bone healing.
The T2 Recon Nail System is supplied as a sterile, single-use orthopedic implant intended for surgical use in orthopedic settings. It is manufactured under FDA 510(k) clearance (K032898) as substantially equivalent to a predicate device, with approval for orthopedic applications. The system includes size-specific nails and screws, ensuring compatibility with femoral anatomy. Storage and handling must adhere to sterile medical device protocols to prevent contamination prior to use. No MRI safety information is specified in the regulatory data.
From the manufacturer
T2 Recon Nailing System With a tip of the greater trochanter entry point and both recon and antegrade femoral locking options, it offers an efficient treatment option for multiple indications. The T2 IM Nailing Platform offers a combination of innovation, simplicity and versatility that is designed to suit your various needs.
Other devices from Howmedica Osteonics Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the T2 Recon Nail System used for?
The T2 Recon Nail System is designed for internal fixation of femoral fractures. Its intramedullary nail and modular locking components—including femoral nails, locking screws, set screws, end caps, and lag screws—offer customizable stabilization to address various fracture patterns and anatomical needs during bone healing.
How is the T2 Recon Nail System supplied and prepared for use?
The system is supplied as a sterile, single-use orthopedic implant. It must be handled under sterile medical device protocols to prevent contamination before surgical use. The modular design ensures compatibility with femoral anatomy through size-specific nails and screws.
Is the T2 Recon Nail System reusable or intended for single-use?
The T2 Recon Nail System is explicitly intended for single-use only. Its sterile packaging and design align with orthopedic implant standards to ensure patient safety and prevent cross-contamination between procedures.
What types of locking options does the system provide for femoral fixation?
The system offers both retrograde and antegrade femoral locking options. This flexibility allows surgeons to select the optimal approach based on fracture location, anatomical considerations, and clinical scenario to achieve stable alignment during healing.
Are there any special storage requirements for the T2 Recon Nail System?
Storage must adhere to sterile medical device protocols to maintain integrity until use. The system’s packaging is designed to preserve sterility, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until ready for surgical preparation.