I.T.S. INS Proximal Femur Nail
FDA 510(k) K233134 · I.T.S. GmbH
510(k) numberK233134
Submission
- Device name
- I.T.S. INS Proximal Femur Nail
- Applicant
- I.T.S. GmbH
Lassnitzhoehe, AT - Received
- September 27, 2023
- Decision date
- February 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
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| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
| K253155 | Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional | Beijing Fule Science & Technology Development… | 06/17/2026SE |
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
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| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…HRS · Traditional | 06/16/2026SE |
| K260054 | I.T.S. PRS Phoenix IIHRS · Traditional | 04/24/2026SE |
| K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)HRS · Traditional | 08/31/2022SE |
| K142418 | I.T.S. Hand Locking Plates System - HLSHRS · Traditional | 09/26/2014SE |
| K132945 | Cfn-Cannulated Femur Nail, Ctn-Cannulated Tibia Nail, Chn-Cannulated Humeral NailHSB · Traditional | 03/07/2014SE |
| K131722 | I.T.S. Extremity Fixation SystemsHRS · Traditional | 08/07/2013SE |
| K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…HRS · Traditional | 06/25/2013SE |
Questions and answers
When was I.T.S. INS Proximal Femur Nail cleared by the FDA?
I.T.S. INS Proximal Femur Nail (K233134) received a 510(k) decision of Substantially Equivalent on February 12, 2024, 138 days after the submission was received.
What is the product code of K233134?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.