Series II X3 Large Diameter Accetabular Inserts
FDA 510(k) K103124 · Stryker Corporation
510(k) numberK103124
Submission
- Device name
- Series II X3 Large Diameter Accetabular Inserts
- Applicant
- Stryker Corporation
Mahwah, NJ, US - Received
- October 22, 2010
- Decision date
- November 19, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | 06/29/2026SE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional | 02/03/2026SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | 12/19/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | 08/13/2025SE |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional | 09/20/2023SE |
Questions and answers
When was Series II X3 Large Diameter Accetabular Inserts cleared by the FDA?
Series II X3 Large Diameter Accetabular Inserts (K103124) received a 510(k) decision of Substantially Equivalent on November 19, 2010, 28 days after the submission was received.
What is the product code of K103124?
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.