FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
implantcast Packaging System Update
K Number: K260037
·
Decision Mar 30, 2026
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
20
Review Days
83
Basic Information
- Device Name
- implantcast Packaging System Update
- K Number
- K260037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implantcast GmbH
- Date Received
- January 6, 2026
- Decision Date
- March 30, 2026
- Product Code
- LZO
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Implantcast GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K252451 | EPORE® XO cup system | Apr 24, 2026 | Substantially Equivalent |
| K252401 | implaFit® short stems | Mar 12, 2026 | Substantially Equivalent |
| K241944 | AGILON® XO Shoulder Replacement System | Mar 10, 2025 | Substantially Equivalent |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Oct 24, 2024 | Substantially Equivalent |
| K234044 | ACS® LD FB Knee System | Sep 6, 2024 | Substantially Equivalent |
| K240834 | EcoFit® short stem cementless cpTi | Jun 3, 2024 | Substantially Equivalent |
| K231657 | AGILON® XO Shoulder Replacement System | Feb 16, 2024 | Substantially Equivalent |
| K232371 | Actinia® hip stems | Oct 19, 2023 | Substantially Equivalent |
| K223103 | BethaLoc® stem cementless HA | Jun 20, 2023 | Substantially Equivalent |
| K222482 | AGILON XO Shoulder System | Sep 28, 2022 | Substantially Equivalent |