THP Hip Fracture Plating System
FDA 510(k) K173826 · Biomet, Inc.
510(k) numberK173826
Submission
- Device name
- THP Hip Fracture Plating System
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- December 18, 2017
- Decision date
- February 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDO – Device, Fixation, Proximal Femoral, Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | OsteoCentric Technologies | 04/18/2023SE |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…JDO · Traditional | Smith & Nephew, Inc. | 09/29/2022SE |
| K210247 | OsteoCentric Integrated Hip Fastener SystemJDO · Traditional | Osteocentric Technologies D.B.A. Osteocentric… | 04/30/2021SE |
| K193029 | Conquest FNJDO · Traditional | Smith & Nephew, Inc. | 02/28/2020SE |
| K172785 | Conquest FNJDO · Special | Smith & Nephew | 12/22/2017SE |
| K152686 | Conquest FNJDO · Traditional | Smith & Nephew | 03/17/2016SE |
| K140018 | TSP Hip Fracture Plating SystemJDO · Traditional | Biomet, Inc. | 04/04/2014SE |
| K080685 | Hiploc Compression Hip ScrewJDO · Traditional | Biomet Manufacturing, Inc. | 08/15/2008SE |
| K080434 | Intertan CHS Locking Plate System Prox Fem Plates/ScrewJDO · Traditional | Smith & Nephew, Inc. | 04/10/2008SE |
| K983814 | Gotfried Percutaneous Compression Plating SystemJDO · Traditional | Efratgo, Ltd. HI Tech Bio-Surgical | 01/14/1999SE |
More from Efratgo, Ltd. HI Tech Bio-Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | 05/19/2026SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | 05/22/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
Questions and answers
When was THP Hip Fracture Plating System cleared by the FDA?
THP Hip Fracture Plating System (K173826) received a 510(k) decision of Substantially Equivalent on February 7, 2018, 51 days after the submission was received.
What is the product code of K173826?
The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.