The Implex Hedrocel Modular Elliptical Acetabular Cup
FDA 510(k) K001039 · Implex Corp.
510(k) numberK001039
Submission
- Device name
- The Implex Hedrocel Modular Elliptical Acetabular Cup
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- March 31, 2000
- Decision date
- June 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K051978 | Trabecular Metal Vertebral Body ReplacementMQP · Special | 09/23/2005SE |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1MQP · Special | 06/17/2005SE |
| K040487 | Trabecular Metal Knee System AugmentsMBH · Traditional | 12/21/2004SE |
| K040630 | Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZJWH · Traditional | 09/30/2004SE |
| K040756 | The Trabecular Metal Reconstruction System, Model 10-340-XXXXXFTM · Special | 07/14/2004SE |
| K031962 | Nexgen Trabecular Metal Tibial Cone AugmentsJWH · Traditional | 01/08/2004SE |
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZJDK · Special | 11/19/2003SE |
| K032527 | Hedrocel Vertebral Body ReplacementMQP · Special | 10/31/2003SE |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | 10/02/2003SE |
| K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…KWS · Traditional | 09/23/2003SE |
Questions and answers
When was The Implex Hedrocel Modular Elliptical Acetabular Cup cleared by the FDA?
The Implex Hedrocel Modular Elliptical Acetabular Cup (K001039) received a 510(k) decision of Substantially Equivalent on June 15, 2000, 76 days after the submission was received.
What is the product code of K001039?
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.