Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CarboFix Orthopedics , Ltd. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
199 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hyb | CarboFix Orthopedics , Ltd. | 2026-03-16 | 89 | 0 |
| K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2024-11-05 | 36 | 0 |
| K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2024-08-01 | 247 | 0 |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid | CarboFix Orthopedics , Ltd. | 2024-04-25 | 29 | 0 |
| K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | 2024-03-27 | 100 | 0 |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated | CarboFix Orthopedics , Ltd. | 2024-01-10 | 27 | 0 |
| K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2023-10-10 | 67 | 0 |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated | CarboFix Orthopedics , Ltd. | 2023-07-03 | 61 | 0 |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated In | CarboFix Orthopedics , Ltd. | 2021-04-06 | 27 | 0 |
| K203317 | CarboClear X Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2020-11-25 | 15 | 0 |
| K201917 | Piccolo Composite Proximal Tibia Plate System | CarboFix Orthopedics , Ltd. | 2020-10-08 | 90 | 0 |
| K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Scr | CarboFix Orthopedics , Ltd. | 2020-08-07 | 28 | 0 |
| K201251 | CarboClear Navigated Instruments | CarboFix Orthopedics , Ltd. | 2020-08-05 | 86 | 0 |
| K200883 | CarboClear® Cervical Plate System | CarboFix Orthopedics , Ltd. | 2020-06-04 | 63 | 0 |
| K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2020-04-30 | 59 | 0 |
| K193378 | CarboClear Lumbar Cage System | CarboFix Orthopedics , Ltd. | 2020-03-02 | 88 | 0 |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | 2019-10-11 | 57 | 0 |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics , Ltd. | 2019-09-19 | 199 | 0 |
| K182015 | Piccolo Composite® Plate System | CarboFix Orthopedics , Ltd. | 2018-10-11 | 76 | 0 |
| K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2018-09-27 | 27 | 0 |
| K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2018-07-18 | 247 | 0 |
| K173652 | Piccolo Composite Nailing System | CarboFix Orthopedics , Ltd. | 2017-12-28 | 30 | 0 |
| K170401 | Piccolo Composite® Plate System | CarboFix Orthopedics , Ltd. | 2017-05-12 | 92 | 0 |
| K160002 | Piccolo Composite(R) Distal Volar Radius Plate System | CarboFix Orthopedics , Ltd. | 2016-03-09 | 65 | 0 |
| K153536 | Piccolo Composite® Nailing System | CarboFix Orthopedics , Ltd. | 2016-01-06 | 27 | 1 |
| K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics , Ltd. | 2015-07-28 | 104 | 1 |
| K143496 | Piccolo Composite Plate System | CarboFix Orthopedics , Ltd. | 2015-05-29 | 171 | 0 |
| K132774 | PICCOLO COMPOSITE NAILING SYSTEM | CarboFix Orthopedics , Ltd. | 2013-10-03 | 28 | 0 |
| K123810 | PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM | CarboFix Orthopedics , Ltd. | 2013-06-14 | 185 | 0 |
| K130061 | PICCOLO COMPOSITE PLATE SYSTEM | CarboFix Orthopedics , Ltd. | 2013-02-27 | 48 | 0 |
| K120409 | PICCOLO COMPOSITE PLATE SYSTEM | CarboFix Orthopedics , Ltd. | 2012-11-26 | 291 | 0 |
| K111056 | PICCOLO COMPOSITE NAILING SYSTEM | CarboFix Orthopedics , Ltd. | 2011-05-03 | 15 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda