RHS Acetabular Component
FDA 510(k) K022382 · Signal Medical Corp.
510(k) numberK022382
Submission
- Device name
- RHS Acetabular Component
- Applicant
- Signal Medical Corp.
Port Huron, MI, US - Received
- July 22, 2002
- Decision date
- October 4, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K203779 | Symmetric Total Knee SystemMBH · Traditional | 06/10/2021SE |
| K100370 | Symmetric Total Knee AgumentsJWH · Traditional | 03/07/2011SE |
| K080199 | Symmetric Total Knee SystemJWH · Traditional | 07/03/2008SE |
| K073674 | Bone Fixation Wire (Kirschner Wire)HTY · Traditional | 03/24/2008SE |
| K051510 | Signal Medical Corporation Beacon Knee SystemMBH · Traditional | 03/22/2006SE |
| K043289 | E-Z Frame External Surgical Support BootKTT · Traditional | 02/11/2005SE |
| K021063 | Great Toe ImplantKWD · Traditional | 07/01/2002SE |
| K981302 | SMC 28MM Ceramic Femoral HeadsLZO · Traditional | 06/25/1998SE |
| K971681 | SMC Femoral Hip ComponentJDI · Traditional | 12/04/1997SE |
| K971018 | SMC Acetabular ComponentLPH · Traditional | 10/24/1997SE |
Questions and answers
When was RHS Acetabular Component cleared by the FDA?
RHS Acetabular Component (K022382) received a 510(k) decision of Substantially Equivalent on October 4, 2002, 74 days after the submission was received.
What is the product code of K022382?
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.