Activelock Modular Femoral Hip System
FDA 510(k) K980020 · Metagen, LLC
510(k) numberK980020
Submission
- Device name
- Activelock Modular Femoral Hip System
- Applicant
- Metagen, LLC
San Diego, CA, US - Received
- January 5, 1998
- Decision date
- April 3, 1998
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K983976 | Metagen Activelock Wire Cerclage SystemJDQ · Traditional | 12/30/1998SE |
| K980609 | Segmental Defect Replacement SystemHSB · Traditional | 05/18/1998SE |
| K964003 | Metagen All Poly Acetabular Cup SystemJDI · Traditional | 03/21/1997SE |
| K963700 | Metagen High Tibial Osteotomy SystemHRS · Traditional | 02/12/1997SE |
Questions and answers
When was Activelock Modular Femoral Hip System cleared by the FDA?
Activelock Modular Femoral Hip System (K980020) received a 510(k) decision of Substantially Equivalent for Some Indications on April 3, 1998, 88 days after the submission was received.
What is the product code of K980020?
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.