Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthofix, Inc. — Predicate Candidate Screening
57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
217 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | Orthofix, Inc. | 2024-05-28 | 70 | 2 |
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR Syst | Orthofix, Inc. | 2021-08-31 | 89 | 0 |
| K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation S | Orthofix, Inc. | 2021-07-30 | 57 | 0 |
| K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021-03-25 | 20 | 0 |
| K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | 2021-03-18 | 125 | 1 |
| K203576 | FORZA Ti Spacer System | Orthofix, Inc. | 2021-03-03 | 86 | 1 |
| K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020-11-18 | 29 | 0 |
| K202949 | CONSTRUX Mini PEEK Spacer System | Orthofix, Inc. | 2020-10-29 | 29 | 0 |
| K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | 2020-10-14 | 30 | 0 |
| K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020-09-15 | 88 | 0 |
| K201481 | Centurion POCT System | Orthofix, Inc. | 2020-06-15 | 11 | 0 |
| K200606 | O-Genesis Graft Delivery System | Orthofix, Inc. | 2020-05-01 | 53 | 0 |
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PI | Orthofix, Inc. | 2020-04-09 | 90 | 0 |
| K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020-04-02 | 16 | 1 |
| K190751 | Connector System | Orthofix, Inc. | 2019-05-22 | 58 | 0 |
| K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019-04-30 | 148 | 0 |
| K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird | Orthofix, Inc. | 2018-08-24 | 213 | 0 |
| K172115 | Navigated Instrument System | Orthofix, Inc. | 2018-03-08 | 238 | 0 |
| K180025 | Centurion POCT System | Orthofix, Inc. | 2018-01-22 | 19 | 0 |
| K172696 | FORZA® XP Expandable Spacer System | Orthofix, Inc. | 2018-01-19 | 134 | 0 |
| K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, | Orthofix, Inc. | 2017-11-02 | 83 | 3 |
| K172194 | Connector System | Orthofix, Inc. | 2017-08-18 | 28 | 0 |
| K170647 | Connector System | Orthofix, Inc. | 2017-05-11 | 69 | 0 |
| K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation | Orthofix, Inc. | 2017-05-05 | 24 | 1 |
| K162921 | Navigated Instrument System | Orthofix, Inc. | 2017-03-13 | 146 | 0 |
| K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PE | Orthofix, Inc. | 2016-12-22 | 112 | 0 |
| K162638 | CETRA Anterior Cervical Plate System | Orthofix, Inc. | 2016-12-16 | 85 | 0 |
| K161129 | PILLAR SA PTC | Orthofix, Inc. | 2016-09-08 | 140 | 0 |
| K161280 | Cervical Stand Alone System | Orthofix, Inc. | 2016-06-17 | 42 | 0 |
| K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation | Orthofix, Inc. | 2016-01-29 | 65 | 1 |
| K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016-01-14 | 136 | 0 |
| K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spac | Orthofix, Inc. | 2015-09-11 | 185 | 0 |
| K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation | Orthofix, Inc. | 2015-07-07 | 35 | 1 |
| K143028 | Azure Anterior Cervical Plate System | Orthofix, Inc. | 2015-05-29 | 220 | 0 |
| K150822 | Centurion POCT System | Orthofix, Inc. | 2015-05-15 | 49 | 0 |
| K142152 | CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICA | Orthofix, Inc. | 2015-01-08 | 155 | 0 |
| K141186 | FIREBIRD SPINAL FIXATION SYSTEM | Orthofix, Inc. | 2015-01-02 | 240 | 0 |
| K140260 | SKYHAWK LATERAL PLATE SYSTEM | Orthofix, Inc. | 2014-07-02 | 149 | 0 |
| K140709 | SKYHAWK INTERBODY FUSION SYSTEM | Orthofix, Inc. | 2014-05-27 | 67 | 0 |
| K132999 | CERVICAL STAND ALONE SYSTEM | Orthofix, Inc. | 2014-04-14 | 202 | 0 |
| K131833 | CENTURION POCT SYSTEM | Orthofix, Inc. | 2014-01-30 | 224 | 0 |
| K130932 | FIREBIRD SPINAL FIXATION SYSTEM | Orthofix, Inc. | 2013-08-07 | 125 | 1 |
| K130825 | AZURE ANTERIOR CERVICAL PLATE SYSTEM | Orthofix, Inc. | 2013-05-07 | 42 | 1 |
| K121658 | ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) | Orthofix, Inc. | 2012-07-20 | 45 | 0 |
| K111448 | ICON (TM) MODULAR PEDICLE SCREW SYSTEM | Orthofix, Inc. | 2012-02-16 | 268 | 0 |
| K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEE | Orthofix, Inc. | 2011-06-21 | 90 | 0 |
| K111183 | ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM | Orthofix, Inc. | 2011-05-24 | 27 | 0 |
| K103111 | FORZA SPACER SYSTEM | Orthofix, Inc. | 2011-03-23 | 153 | 1 |
| K102201 | CONTOURS LAPIDUS PLATING SYSTEM | Orthofix, Inc. | 2010-12-15 | 133 | 0 |
| K101936 | CONTOURS VSP III VOLAR PLATING SYSTEM | Orthofix, Inc. | 2010-10-20 | 100 | 0 |
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