Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
FDA 510(k) K212431 · Biomet, Inc.
510(k) numberK212431
Submission
- Device name
- Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- August 4, 2021
- Decision date
- February 7, 2022
- 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 |
|---|---|---|---|
| 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 |
| K951083 | Proform Cemented Femoral ComponentJDG · Traditional | Stelkast Company | 05/22/1995SN |
More from Stelkast Company
| 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 |
| 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 |
| K193546 | Distal CentralizersJDG · Traditional | 09/25/2020SE |
Questions and answers
When was Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve cleared by the FDA?
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (K212431) received a 510(k) decision of Substantially Equivalent on February 7, 2022, 187 days after the submission was received.
What is the product code of K212431?
The FDA product code is JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.