COPAL® exchange G hip spacer; COPAL® G+V
FDA 510(k) K234028 · Heraeus Medical GmbH
510(k) numberK234028
Submission
- Device name
- COPAL® exchange G hip spacer; COPAL® G+V
- Applicant
- Heraeus Medical GmbH
Wehrheim, DE - Received
- December 20, 2023
- Decision date
- February 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL · Traditional | Depuy Ireland UC | 05/15/2026SE |
| K253675 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 12/23/2025SE |
| K252326 | InterSpace GV Hip SpacerKWL · Special | Tecres S.P.A. | 08/06/2025SE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | Biocomposites, Ltd. | 06/12/2025SE |
| K222632 | UHR Bipolar Implants, Restoration GAP II ImplantsKWL · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/21/2022SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | Osteoremedies, LLC | 08/23/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | Osteoremedies, LLC | 08/29/2018SE |
| K173967 | Remedy Acetabular CupKWL · Traditional | Osteoremedies, LLC | 02/22/2018SE |
More from Osteoremedies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K241674 | Osteopal® VLOD · Traditional | 12/05/2024SE |
| K222570 | COPAL knee mouldsJWH · Traditional | 02/04/2023SE |
| K220492 | COPAL exchange G hip spacerKWY · Special | 03/23/2022SE |
| K213812 | PALACOS MV proLOD · Traditional | 02/02/2022SE |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional | 07/09/2021SE |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD · Traditional | 11/23/2020SE |
| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | 11/01/2019SE |
| K190766 | PALACOS fast R+GLOD · Traditional | 05/31/2019SE |
| K182260 | Palacos MVLOD · Special | 09/17/2018SE |
| K153737 | OSTEOPAL plusLOD · Special | 04/22/2016SE |
Questions and answers
When was COPAL® exchange G hip spacer; COPAL® G+V cleared by the FDA?
COPAL® exchange G hip spacer; COPAL® G+V (K234028) received a 510(k) decision of Substantially Equivalent on February 15, 2024, 57 days after the submission was received.
What is the product code of K234028?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.