Intellijoint Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Intellijoint Surgical, Inc.” (first 2014, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 158 days. Since 2017 the median was 148 days, against 113 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 224 |
| 2015 | 1 | 221 |
| 2016 | 0 | — |
| 2017 | 3 | 158 |
| 2018 | 0 | — |
| 2019 | 1 | 117 |
| 2020 | 0 | — |
| 2021 | 1 | 148 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intellijoint Surgical, Inc. took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Orthopedic (6)
- Radiology (1)
Most recent Intellijoint Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211876 | Intellijoint VIEW | LLZ | 2021-11-12 | 148 |
| K191507 | Intellijoint® Navigation System | OLO | 2019-10-01 | 117 |
| K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | OLO | 2017-11-16 | 57 |
| K171525 | Intellijoint HIP Generation 2B System | OLO | 2017-10-30 | 158 |
| K162364 | Intellijoint HIP Generation 2A System | OLO | 2017-03-02 | 191 |
| K151364 | Intellijoint HIP(tm) System | OLO | 2015-12-28 | 221 |
| K133759 | INTELLIJOINT HIP | OLO | 2014-07-23 | 224 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-02-11.
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 Intellijoint Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Intellijoint Surgical, Inc.” (first 2014, latest 2021), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intellijoint Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intellijoint Surgical, Inc. is 158 days. Since 2017: 148 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Intellijoint Surgical, Inc.?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 6); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 7 Intellijoint Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLO, Intellijoint Surgical, Inc.'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.