S2 Femoral A/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail
FDA 510(k) K113409 · Howmedica Osteonics Corp.
510(k) numberK113409
Submission
- Device name
- S2 Femoral A/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail
- Applicant
- Howmedica Osteonics Corp.
Mahwah, NJ, US - Received
- November 18, 2011
- Decision date
- February 15, 2012
- 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
Other 510(k)s with product code HSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| 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 |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit CupJDI · Traditional | 08/13/2020SE |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…MBH · Traditional | 05/13/2020SE |
| K130895 | Reunion Rsa Shoulder SystemPHX · Traditional | 12/27/2013SE |
| K123604 | Abg III Monolithic Hip StemMAY · Traditional | 08/16/2013SE |
| K122015 | Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…KRO · Traditional | 02/22/2013SE |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…JWH · Traditional | 02/14/2013SE |
| K122853 | Novel Fit and Fill StemMEH · Traditional | 02/01/2013SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | 11/01/2012SE |
| K121308 | Hip SystemsLPH · Traditional | 07/30/2012SE |
| K120578 | Accolade II Hip StemJDI · Special | 03/29/2012SE |
Questions and answers
When was S2 Femoral A/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail cleared by the FDA?
S2 Femoral A/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail (K113409) received a 510(k) decision of Substantially Equivalent on February 15, 2012, 89 days after the submission was received.
What is the product code of K113409?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.