| K-number | K252401 |
| Device name | implaFit® short stems |
| Applicant | Implantcast GmbH |
| Product code | LZO |
| Device class | Class II |
| Decision date | Mar 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3353 |
The implaFit® short stems are titanium alloy femoral hip stem components intended for use in total and partial (hemi) hip arthroplasty procedures. They are designed for uncemented, press-fit fixation and are indicated for conditions including osteoarthritis, rheumatoid arthritis, femoral neck fractures, and revision of failed hip replacements.
The device is a straight, monoblock, tapered femoral hip stem design offered in standard and lateralized offset versions with collar in cementless configuration. Key design features are equivalent to the predicate implaFit® hip stem, though there are minor differences in stem shape, dimensions, and coating characteristics.
ISO 7206-4, ISO 7206-6, ISO 21535, ASTM F2582, ASTM F2009, ISO 7206-13, ASTM F2024, ASTM F1854, ASTM F1160, ASTM F1147, ASTM F1044, ASTM F1978, ASTM F1185, ASTM F1609, ASTM F1926, ISO 13179-1, ISO 13779-2, ISO 13779-3, and ISO 13779-6.
The subject device and predicate implaFit® hip stem share the same intended use, similar technological characteristics, and are made of similar materials with similar packaging and sterilization methods. All performance testing met predetermined acceptance criteria, demonstrating substantial equivalence despite minor differences in stem shape, dimensions, and coating.
View the full FDA submission: accessdata.fda.gov