implantcast Packaging System Update— 510(k) K260037
Substantially EquivalentImplantcast GmbH
FDA 510(k) clearance K260037 for implantcast Packaging System Update, Substantially Equivalent on 2026-03-30. Applicant: Implantcast GmbH. Device class: 2.
Summary
Implantcast's implantcast Packaging System Update is filed under LZO, semi-constrained metal/ceramic/polymer hip prostheses (cemented, or non-porous uncemented). The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 888.3353. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Implantcast filed from Buxtehude, Germany. The decision came 83 calendar days after receipt (January 6 to March 30, 2026).
Clearance details
- Applicant
- Implantcast GmbH
- Product code
- Product code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buxtehude, DE
Recent devices under product code LZO
view allMore clearances from Implantcast GmbH
view allAdverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.