Ionguard Titanium Modular Heads
FDA 510(k) K915548 · Biomet, Inc.
510(k) numberK915548
Submission
- Device name
- Ionguard Titanium Modular Heads
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- December 11, 1991
- Decision date
- March 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231448 | TANDEM Hip SystemLZY · Traditional | Smith & Nephew, Inc. | 07/19/2023SE |
| K111145 | Endo HeadLZY · Traditional | Medacta International | 08/16/2011SE |
| K974442 | Pre-Powdered Nitrile Examination GlovesLZY · Traditional | P.T. Latexindo Tobaperkasa | 01/05/1998SE |
| K915528 | BHR Bipolar Femoral Head ComponentLZY · Traditional | Implantology Corp. | 06/29/1993SE |
| K903084 | Modular Cathcart Fracture SystemLZY · Traditional | Depuy, Inc. | 10/03/1990SE |
| K896580 | Uni-Polar HeadLZY · Traditional | Richards Medical Co., Inc. | 02/15/1990SE |
| K892059 | Femoral Heads/Modular & Fixed W/ Titan Nitride SurLZY · Traditional | Protek, Inc. | 07/19/1989SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
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| 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 Ionguard Titanium Modular Heads cleared by the FDA?
Ionguard Titanium Modular Heads (K915548) received a 510(k) decision of Substantially Equivalent on March 10, 1992, 90 days after the submission was received.
What is the product code of K915548?
The FDA product code is LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball, a Class II (moderate risk) device regulated under 21 CFR 888.3360.