Triad II Modular Total Hip System
FDA 510(k) K003199 · Osteoimplant Technology, Inc.
510(k) numberK003199
Submission
- Device name
- Triad II Modular Total Hip System
- Applicant
- Osteoimplant Technology, Inc.
Hunt Valley, MD, US - Received
- October 12, 2000
- Decision date
- January 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K040685 | Z - Series Modular Total Hip System Plasma CoatedLWJ · Traditional | 01/25/2005SE |
| K041443 | Oti Alumina Ceramic Femoral Head SystemLZO · Special | 11/16/2004SE |
| K040225 | Oti Alumina Ceramic Femoral Head SystemKWZ · Traditional | 05/06/2004SE |
| K032729 | Z-Series Modular Total Hip SystemLPH · Traditional | 12/03/2003SE |
| K030608 | Oti Bone Cement PlugJDK · Traditional | 06/12/2003SESU |
| K022779 | Oti Unicondular Interpositional SpacerHSH · Traditional | 11/20/2002SE |
| K021822 | R120 Modular Total Hip SystemJDI · Traditional | 07/23/2002SE |
| K012762 | MJS Posterior Stabilized Knee SystemHRY · Traditional | 12/11/2001SE |
| K011774 | R120 Modular Total Hip SystemJDI · Traditional | 09/05/2001SE |
| K003316 | Oti Ceramic Femoral Head SystemLZO · Traditional | 01/19/2001SE |
Questions and answers
When was Triad II Modular Total Hip System cleared by the FDA?
Triad II Modular Total Hip System (K003199) received a 510(k) decision of Substantially Equivalent on January 10, 2001, 90 days after the submission was received.
What is the product code of K003199?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.