Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
FDA 510(k) K242865 · Biocomposites, Ltd.
510(k) numberK242865
Submission
- Device name
- Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
- Applicant
- Biocomposites, Ltd.
Keele, GB - Received
- September 20, 2024
- Decision date
- June 12, 2025
- 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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| K073341 | Genex PuttyMQV · Traditional | 07/09/2008SE |
| K081428 | Modification to Doubleplay Suture AnchorHWC · Special | 06/20/2008SE |
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Questions and answers
When was Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer cleared by the FDA?
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (K242865) received a 510(k) decision of Substantially Equivalent on June 12, 2025, 265 days after the submission was received.
What is the product code of K242865?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.