Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
FDA 510(k) K152171 · Orthofix Srl
510(k) numberK152171
Submission
- Device name
- Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
- Applicant
- Orthofix Srl
Bussolengo, IT - Received
- August 4, 2015
- Decision date
- September 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
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| K250112 | FitboneTM TrochantericHSB · Traditional | 04/10/2025SE |
| K242270 | OrthoNext Platform SystemQIH · Traditional | 12/19/2024SE |
| K242861 | TrueLok ElevateKTT · Traditional | 12/03/2024SE |
| K233867 | Fitbone TrochantericHSB · Traditional | 06/18/2024SE |
| K240749 | PILLAR SA Ti Spacer System (82-XXX)MAX · Traditional | 05/28/2024SE |
| K232648 | RODEO Telescopic NailHSB · Traditional | 05/03/2024SE |
| K232169 | FITBONE® Transport and Lengthening SystemHSB · Traditional | 03/22/2024SE |
| K213572 | JuniOrtho Plating SystemHWC · Traditional | 01/18/2022SE |
Questions and answers
When was Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 cleared by the FDA?
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (K152171) received a 510(k) decision of Substantially Equivalent on September 28, 2015, 55 days after the submission was received.
What is the product code of K152171?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.