Bioball Delta Ceramic Heads, Multicup Pe Inlay Standard
FDA 510(k) K141377 · Merete Medical GmbH
510(k) numberK141377
Submission
- Device name
- Bioball Delta Ceramic Heads, Multicup Pe Inlay Standard
- Applicant
- Merete Medical GmbH
Berlin, DE - Received
- May 27, 2014
- Decision date
- November 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | Waldemar Link GmbH & Co. KG | 07/06/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | Zimmer, Inc. | 06/16/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | Zimmer, Inc. | 04/27/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | Implantcast GmbH | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | Implantcast GmbH | 03/12/2026SE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | Maxx Orthopedics, Inc. | 01/15/2026SE |
| K250450 | Coated hip implantsLZO · Traditional | Medacta International S.A. | 09/19/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | Signature Orthopaedics Pty, Ltd. | 08/07/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | Zimmer, Inc. | 07/18/2025SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160548 | MC-Subtalar(TM) IIHWC · Traditional | 04/29/2016SE |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…HWC · Traditional | 02/12/2016SE |
| K151762 | PediatrOS RigidTack/FlexTackJDR · Traditional | 12/28/2015SE |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemHSB · Traditional | 02/09/2015SE |
| K140069 | Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS 3.0HRS · Traditional | 04/07/2014SE |
| K132226 | Metafix BLP Plate, Size 31, Left, Metafix BLP Plate, Size 31,RIGHTHRS · Special | 08/09/2013SE |
| K123619 | Intrablock Bioball Hip System (Ibs)LZO · Traditional | 05/24/2013SE |
| K130400 | Meretec CS, Cortical ScrewsHWC · Special | 04/05/2013SE |
| K120787 | Merete Locking Bone Plate System IIIHRS · Traditional | 11/27/2012SE |
| K120978 | Osteobridge Ika Knee Arthodesis Nail with CollarHSB · Special | 05/02/2012SE |
Questions and answers
When was Bioball Delta Ceramic Heads, Multicup Pe Inlay Standard cleared by the FDA?
Bioball Delta Ceramic Heads, Multicup Pe Inlay Standard (K141377) received a 510(k) decision of Substantially Equivalent on November 21, 2014, 178 days after the submission was received.
What is the product code of K141377?
The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.