Implant Technology, Inc.: FDA clearances and approvals
Implant Technology, Inc. has 13 FDA 510(k) clearances (first 1983, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time: 64 days.
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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 6 | 6 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 | 3 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| LZV | System, Cement Removal Extraction | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
Review panels
- Orthopedic (10)
- Anesthesiology (3)
Most recent Implant Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921525 | HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS | LPH | 1995-01-11 | 1013 |
| K915617 | LSF HA COATED FEMORAL HIP | MEH | 1992-05-28 | 164 |
| K920021 | LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP | JDI | 1992-03-25 | 83 |
| K913616 | LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP | JDI | 1991-11-07 | 86 |
| K902727 | LSF CEMENTED FEMORAL HIP | JDI | 1990-08-09 | 49 |
| K901460 | LSF(TM) TOTAL HIP SYSTEM | JDI | 1990-05-22 | 55 |
| K891472 | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR | LZV | 1989-05-02 | 48 |
| K884432 | MODIFIED LSF TOTAL HIP SYSTEM | JDI | 1988-12-09 | 49 |
| K883212 | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | KXA | 1988-11-22 | 116 |
| K855017 | LSF* TOTAL HIP SYSTEM | JDI | 1986-06-11 | 177 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Implant Technology, Inc..
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 Implant Technology, Inc. have?
Implant Technology, Inc. has 13 FDA 510(k) clearances (first 1983, latest 1995), across 6 product codes in 2 review panels.
How long does FDA take to clear Implant Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Implant Technology, Inc.'s cleared 510(k)s is 64 days.
What devices does Implant Technology, Inc. make?
Its most frequent FDA product codes are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 6); BTO (Tube, Tracheostomy (W/Wo Connector), 3); KXA (Prosthesis, Hip, Femoral, Resurfacing, 1).
Has Implant Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Implant Technology, Inc. Related entities may recall under other names.
Next steps
- See all 13 Implant Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Implant Technology, Inc.'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.