Implantcast GmbH: FDA clearances and approvals
Implantcast GmbH has 20 FDA 510(k) clearances (first 2017, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time: 252 days. Since 2017 its median was 252 days, against 93 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Implantcast GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 279 |
| 2018 | 1 | 171 |
| 2019 | 2 | 170 |
| 2020 | 2 | 408 |
| 2021 | 2 | 66 |
| 2022 | 2 | 286 |
| 2023 | 2 | 168 |
| 2024 | 4 | 256 |
| 2025 | 1 | 251 |
| 2026 | 3 | 224 |
Review time against the same product codes
Since 2017, Implantcast GmbH's cleared 510(k)s took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 10 | 10 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 3 | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (20)
Most recent Implantcast GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252451 | EPORE® XO cup system | OQI | 2026-04-24 | 263 |
| K260037 | implantcast Packaging System Update | LZO | 2026-03-30 | 83 |
| K252401 | implaFit® short stems | LZO | 2026-03-12 | 224 |
| K241944 | AGILON® XO Shoulder Replacement System | KWT | 2025-03-10 | 251 |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | LZO | 2024-10-24 | 259 |
| K234044 | ACS® LD FB Knee System | JWH | 2024-09-06 | 260 |
| K240834 | EcoFit® short stem cementless cpTi | LZO | 2024-06-03 | 69 |
| K231657 | AGILON® XO Shoulder Replacement System | KWT | 2024-02-16 | 254 |
| K232371 | Actinia® hip stems | LZO | 2023-10-19 | 72 |
| K223103 | BethaLoc® stem cementless HA | LZO | 2023-06-20 | 263 |
10 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2021-05-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Implantcast GmbH have?
Implantcast GmbH has 20 FDA 510(k) clearances (first 2017, latest 2026), across 8 product codes in 1 review panel.
How long does FDA take to clear Implantcast GmbH's 510(k)s?
The median time from FDA receipt to decision across Implantcast GmbH's cleared 510(k)s is 252 days. Since 2017: 252 days, versus 93 days for all cleared 510(k)s in the same product codes.
What devices does Implantcast GmbH make?
Its most frequent FDA product codes are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 10); KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, 3); MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, 2).
Has Implantcast GmbH had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Implantcast GmbH; the most recent began 2021-05-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 20 Implantcast GmbH clearances with predicates and recalls
- Run predicate analysis for product code LZO, Implantcast GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.