Osteoimplant Technology, Inc.: FDA clearances and approvals
Osteoimplant Technology, Inc. has 21 FDA 510(k) clearances (first 1996, latest 2005), across 9 product codes in 1 review panel. Median 510(k) review time: 90 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 | 7 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 6 | 6 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| HSH | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 1 | 1 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 1 | 1 |
Review panels
- Orthopedic (21)
Most recent Osteoimplant Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | LWJ | 2005-01-25 | 315 |
| K041443 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | LZO | 2004-11-16 | 168 |
| K040225 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | KWZ | 2004-05-06 | 94 |
| K032729 | Z-SERIES MODULAR TOTAL HIP SYSTEM | LPH | 2003-12-03 | 91 |
| K030608 | OTI BONE CEMENT PLUG | JDK | 2003-06-12 | 106 |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | HSH | 2002-11-20 | 90 |
| K021822 | R120 MODULAR TOTAL HIP SYSTEM | JDI | 2002-07-23 | 49 |
| K012762 | MJS POSTERIOR STABILIZED KNEE SYSTEM | HRY | 2001-12-11 | 116 |
| K011774 | R120 MODULAR TOTAL HIP SYSTEM | JDI | 2001-09-05 | 90 |
| K003316 | OTI CERAMIC FEMORAL HEAD SYSTEM | LZO | 2001-01-19 | 88 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Osteoimplant 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 Osteoimplant Technology, Inc. have?
Osteoimplant Technology, Inc. has 21 FDA 510(k) clearances (first 1996, latest 2005), across 9 product codes in 1 review panel.
How long does FDA take to clear Osteoimplant Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Osteoimplant Technology, Inc.'s cleared 510(k)s is 90 days.
What devices does Osteoimplant Technology, Inc. make?
Its most frequent FDA product codes are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 7); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 6); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 2).
Has Osteoimplant Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Osteoimplant Technology, Inc. Related entities may recall under other names.
Next steps
- See all 21 Osteoimplant Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, Osteoimplant 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.