Organization (Industry)
RTI Surgical (United States)
ClinicalTrials.gov lists RTI Surgical (United States) as lead sponsor of 16 trials.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.6 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers RTI Surgical (United States): 16 lead-sponsored trials and 1 legal-entity registration. Part of Xtant Medical Holdings, Inc..
Disease areas (11)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Intervertebral Disc Degeneration | 6 |
| Knee Injuries | 4 |
| Spondylolisthesis | 4 |
| Spondylosis | 4 |
| Spinal Stenosis | 3 |
Showing 5 of 11 disease areas.
Trials by start year as sponsor or collaborator (16)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2025 | 1 |
| 2024 | 1 |
| 2023 | 1 |
| 2019 | 3 |
| 2018 | 1 |
| 2017 | 2 |
| 2016 | 1 |
| 2015 | 2 |
| 2014 | 1 |
| 2013 | 1 |
Showing 10 of 16 years.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 43% hit target (n=7) | 63% on time (n=8) |
Journals published in (5)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Foot and ankle clinics | 1 |
| Journal of Korean Neurosurgical Society | 1 |
| Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia | 1 |
| Journal of neurosurgery. Spine | 1 |
| The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 203 | 14 | 2024-08-13 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 20 |
FDA recalls (56)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Class II | 2021-01-15 |
| CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Class II | 2021-01-15 |
| CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Class II | 2021-01-15 |
| CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Class II | 2021-01-15 |
| CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Class II | 2021-01-15 |
Showing 5 of 56 recalls.
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | ALACHUA, US | FDA | |
| Pioneer Surgical Technology, Inc. | Marquette, US | FDA |
Latest dated events (303)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-01-30 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-09-21 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-11-22 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-08-13 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2024-06-14 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 303 events.
CLIA clinical laboratory certificates (1)
| Lab | Certificate | Status |
|---|---|---|
| RTI SURGICAL INC | Certificate of compliance | Terminated |
Biomarker capability evidence (11)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ADM | Trial collaborator | Named in trial inclusion criteria |
| LAT | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial exclusion criteria |
| BMP2 | Trial sponsor | Named in trial exclusion criteria |
| BMP2 | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 11 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, organization relationships, and biomarkers this organization publishes on.