Spheristem Total Hip Prosthesis
FDA 510(k) K780497 · American Ortomed Corp.
510(k) numberK780497
Submission
- Device name
- Spheristem Total Hip Prosthesis
- Applicant
- American Ortomed Corp.
Mchenry, IL, US - Received
- March 28, 1978
- Decision date
- June 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG · Traditional | Stryker Orthopaedics | 03/19/2018SE |
| 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 |
More from Orthomet, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842518 | Uniloc-Cementless & Self Tap AcetabularKWA · Traditional | 01/30/1985SE |
| K842466 | Titanium Mittelmeier Type AcetabularKWA · Traditional | 01/30/1985SE |
| K842465 | UnilocKWL · Traditional | 11/19/1984SE |
| K840413 | Cement RestrictorJDK · Traditional | 03/05/1984SE |
| K820719 | The Icr Knee · Traditional | 05/12/1982SE |
Questions and answers
When was Spheristem Total Hip Prosthesis cleared by the FDA?
Spheristem Total Hip Prosthesis (K780497) received a 510(k) decision of Substantially Equivalent on June 14, 1978, 78 days after the submission was received.
What is the product code of K780497?
The FDA product code is JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.