Implantology Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Implantology Corp.” (first 1993, latest 1994), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 518 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 3 | 3 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Implantology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934729 | UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED | MEH | 1994-07-22 | 296 |
| K915529 | FPC/SFPC/RFPC ACETABULAR COMPONENT | JDL | 1993-07-13 | 581 |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | LZY | 1993-06-29 | 567 |
| K915527 | CPS ACETABULAR COMPONENT | JDL | 1993-06-24 | 562 |
| K915385 | PPC HIP STEM COMPONENT | JDG | 1993-05-17 | 535 |
| K924099 | UFC HIP STEM COMPONENT | JDG | 1993-04-30 | 260 |
| K915391 | FPC HIP STEM COMPONENT | JDG | 1993-04-30 | 518 |
| K915798 | PSK POSTERIOR STABILIZED TOATAL KNEE | JWH | 1993-03-04 | 436 |
| K915584 | CRK CONDYLAR RESURFACING TOTAL KNEE | JWH | 1993-02-12 | 427 |
Recalls
openFDA lists no recalls under a recalling firm named Implantology Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Implantology Corp.?
FDA lists 9 510(k) clearances under the applicant name “Implantology Corp.” (first 1993, latest 1994), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Implantology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implantology Corp. is 518 days.
Which FDA product codes appear under Implantology Corp.?
The most frequent FDA product codes under this applicant name are JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal, 3); JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), 2); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2).
Next steps
- See all 9 Implantology Corp. clearances with predicates and recalls
- Run predicate analysis for product code JDG, Implantology Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.