United U2 femoral head, 22mm delta ceramic head
FDA 510(k) K221675 · United Orthopedic Corporation
510(k) numberK221675
Submission
- Device name
- United U2 femoral head, 22mm delta ceramic head
- Applicant
- United Orthopedic Corporation
Hsinchu City, TW - Received
- June 9, 2022
- Decision date
- November 4, 2022
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | 09/02/2026SE |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type)JWH · Special | 09/25/2025SE |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | 08/22/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | 07/31/2025SE |
| K242315 | Resolve Modular Revision Hip StemMEH · Traditional | 05/01/2025SE |
| K243466 | Conformity Stem Extension Line, #0LZO · Traditional | 01/06/2025SE |
| K243024 | Cellbrick Knee SpacerJWH · Traditional | 12/20/2024SE |
| K242249 | Conformity Stem Extension LineLZO · Special | 08/30/2024SE |
| K221705 | U2 Total Knee System-PF+MBH · Traditional | 02/28/2023SE |
| K221149 | U-Motion II Acetabular System-Extension lineLZO · Traditional | 01/05/2023SE |
Questions and answers
When was United U2 femoral head, 22mm delta ceramic head cleared by the FDA?
United U2 femoral head, 22mm delta ceramic head (K221675) received a 510(k) decision of Substantially Equivalent on November 4, 2022, 148 days after the submission was received.
What is the product code of K221675?
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.