CarboFix Orthopedics , Ltd.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “CarboFix Orthopedics , Ltd.” (first 2011, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 64 days. Since 2017 the median was 63 days, against 90 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 |
|---|---|---|
| 2012 | 1 | 291 |
| 2013 | 3 | 48 |
| 2014 | 0 | — |
| 2015 | 2 | 138 |
| 2016 | 2 | 46 |
| 2017 | 2 | 61 |
| 2018 | 3 | 76 |
| 2019 | 2 | 128 |
| 2020 | 7 | 63 |
| 2021 | 1 | 27 |
| 2022 | 0 | — |
| 2023 | 2 | 64 |
| 2024 | 5 | 36 |
| 2025 | 0 | — |
| 2026 | 1 | 89 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CarboFix Orthopedics , Ltd. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 12 | 12 |
| HRS | Plate, Fixation, Bone | 7 | 7 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| NKG | Posterior Cervical Screw System | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 1 | 1 |
Review panels
- Orthopedic (32)
Most recent CarboFix Orthopedics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | NKG | 2026-03-16 | 89 |
| K243106 | CarboClear® Hybrid Pedicle Screw System | NKB | 2024-11-05 | 36 |
| K233793 | CarboClear® X Pedicle Screw System | NKB | 2024-08-01 | 247 |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement | NKB | 2024-04-25 | 29 |
| K233989 | CarboClear® Posterior Cervical Screw System | NKG | 2024-03-27 | 100 |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | NKB | 2024-01-10 | 27 |
| K232341 | CarboClear® Pedicle Screw System | NKB | 2023-10-10 | 67 |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | NKB | 2023-07-03 | 61 |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | NKB | 2021-04-06 | 27 |
| K203317 | CarboClear X Pedicle Screw System | NKB | 2020-11-25 | 15 |
22 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-05-10.
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.
Device clinical trials
An industry sponsor named CarboFix Orthopedics , Ltd. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02626624: Safety and Efficacy of the CarboClear Pedicle Screw System (Completed, started 2015-12-27)
- NCT02039232: Safety and Efficacy of the CarboFix Pedicle Screw System (Completed, started 2014-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Carbofix Orthpedics , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under CarboFix Orthopedics , Ltd.?
FDA lists 32 510(k) clearances under the applicant name “CarboFix Orthopedics , Ltd.” (first 2011, latest 2026), across 9 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 CarboFix Orthopedics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CarboFix Orthopedics , Ltd. is 64 days. Since 2017: 63 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CarboFix Orthopedics , Ltd.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 12); HRS (Plate, Fixation, Bone, 7); HSB (Rod, Fixation, Intramedullary And Accessories, 6).
Next steps
- See all 32 CarboFix Orthopedics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NKB, CarboFix Orthopedics , Ltd.'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.