implaFit® short stems— 510(k) K252401
Substantially EquivalentImplantcast GmbH
FDA 510(k) clearance K252401 for implaFit® short stems, Substantially Equivalent on 2026-03-12. Applicant: Implantcast GmbH. Device class: 2.
Summary
Implantcast's implaFit® short stems are filed under LZO, semi-constrained metal/ceramic/polymer hip prostheses (cemented, or non-porous uncemented). The record doesn't list stem sizes.
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 224 calendar days after receipt (July 31, 2025 to March 12, 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.