Acuitive Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Acuitive Technologies, Inc.” (first 2020, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 202 days. Since 2017 the median was 202 days, against 85 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 |
|---|---|---|
| 2020 | 1 | 202 |
| 2021 | 2 | 56 |
| 2022 | 1 | 227 |
| 2023 | 2 | 148 |
| 2024 | 1 | 265 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acuitive Technologies, Inc. took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 85 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 5 | 5 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Acuitive Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240450 | Citrepore | MQV | 2024-11-06 | 265 |
| K232592 | CITRELOCK® DUO | MBI | 2023-09-20 | 26 |
| K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants | MAI | 2023-02-14 | 270 |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL | MAI | 2022-11-04 | 227 |
| K210239 | CITRESPLINE and CITRELOCK ACL Implants | MAI | 2021-02-24 | 26 |
| K203334 | The Citrefix Knotless Suture Anchor | MAI | 2021-02-05 | 85 |
| K200725 | Citregen Tendon Interference Screw and Citrelock | MAI | 2020-10-07 | 202 |
Recalls
openFDA lists no recalls under a recalling firm named Acuitive Technologies, Inc..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Acuitive Technologies, Inc. (6)
- Acuitive Technologies (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acuitive Technologies, Inc.?
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Acuitive Technologies, Inc.” (first 2020, latest 2024), across 3 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 Acuitive Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acuitive Technologies, Inc. is 202 days. Since 2017: 202 days, versus 85 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Acuitive Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 5); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 1); MQV (Filler, Bone Void, Calcium Compound, 1).
Next steps
- See all 7 Acuitive Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAI, Acuitive Technologies, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.