Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
FDA 510(k) K173499 · Stryker Orthopaedics
510(k) numberK173499
Submission
- Device name
- Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
- Applicant
- Stryker Orthopaedics
Mahwah, NJ, US - Received
- November 13, 2017
- Decision date
- March 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | Biomet, Inc. | 02/07/2022SE |
| K193546 | Distal CentralizersJDG · Traditional | Biomet, Inc. | 09/25/2020SE |
| K001984 | Progeny Forged Cocr Cemented Femoral ComponentJDG · Traditional | Stelkast Company | 09/27/2000SE |
| K992234 | The Taper-Fit Total Hip SystemJDG · Traditional | Corin USA | 11/10/1999SE |
| K962002 | Aura Hip System Calcar Replacement Femoral StemJDG · Traditional | Exactech, Inc. | 08/08/1996SE |
| K955171 | Nexlock Femoral StemJDG · Traditional | Nexmed, Inc. | 02/09/1996SE |
| K953653 | Lubinus SP II Hip SystemJDG · Traditional | Turnkey Intergration USA, Inc. | 11/06/1995SE |
| K953067 | Hip Fracture Stem Fenestration PlugJDG · Traditional | Howmedica Corp. | 08/21/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | Orthomet, Inc. | 05/30/1995SE |
| K951083 | Proform Cemented Femoral ComponentJDG · Traditional | Stelkast Company | 05/22/1995SN |
More from Stelkast Company
| 510(k) | Device | Decision |
|---|---|---|
| K211703 | Insignia Hip StemMEH · Traditional | 08/16/2021SE |
| K191414 | EXETER Centralizer, EXETER 2.5mm PlugJDI · Traditional | 08/28/2019SE |
| K173849 | Triathlon Total Knee SystemMBH · Traditional | 02/02/2018SE |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH · Traditional | 10/30/2017SE |
| K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateLPH · Traditional | 05/25/2016SE |
| K151264 | Restoration Anatomic ShellLPH · Traditional | 08/10/2015SE |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…LPH · Traditional | 02/09/2015SE |
| K143393 | Triathlon Tritanium Cone AugmentsMBH · Traditional | 01/13/2015SE |
| K142462 | Restoration Anatomic ShellLPH · Traditional | 11/14/2014SE |
| K141056 | Triathlon Knee System Posterior Stabilized ComponentsMBH · Traditional | 08/05/2014SE |
Questions and answers
When was Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads cleared by the FDA?
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (K173499) received a 510(k) decision of Substantially Equivalent on March 19, 2018, 126 days after the submission was received.
What is the product code of K173499?
The FDA product code is JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.