Companies / CTL Amedica

Medical device company profile

CTL Amedica

Spinal fixation and fusion implants with silicon-nitride and titanium product families.

Medical Device ManufacturerOrthopedics & MusculoskeletalSpineCommercial-stage

Headquarters🇺🇸Carrollton, Texas, United States

Founded2014

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitectlamedica.com ↗

Company overview

CTL Amedica designs, develops and manufactures spinal implants, with manufacturing and distribution headquarters in Carrollton, Texas, and an R&D center in Blue Bell, Pennsylvania. Its portfolio spans cervical and lumbar fixation and fusion systems.

The NITRO family uses silicon nitride, while other offerings include titanium and proprietary textured surfaces. The reviewed NITRO clearance is linked to the interbody fusion cage family; material properties and bench findings should not be treated as proof of clinical superiority for all patients.

Founded in 2014, the company is led by founder and CEO Daniel Chon. CTL Amedica is profiled as an implant manufacturer, separately from SINTX’s materials platform and newer surgical-device business. The broad legacy Valeo and fixation portfolio is not represented as fully reconciled by this selected-record review.

^[1][2][3][5]

Leadership

4 people

Daniel ChonFounder & Chief Executive Officer ^[1]

Fiona LazarowChief Financial Officer ^[1]

Sean SuhChief Technology Officer ^[1]

Joy MazzaVice President of Sales & Marketing ^[1]

Products & regulatory status How does MedTechIndex get this information?

Summary

CTL Amedica’s NITRO and broader spinal implant portfolio have a substantial 510(k) history under CTL Medical and the acquired Amedica orthopedic lineage. The audit adds those records while keeping unrelated Amedica Biotech drug tests out. Older authorization records alone do not establish current availability of every model. ^{[2][3][4][52][53][55]}

The matched FDA history contains 2 distinct recall events: 0 open, 1 terminated, and 1 with another/undetermined closure status. Z-2501-2020 (2019-08-21; completed): Reports received of the device fracturing during insertion. Z-1030-2019 (2018-07-05; terminated): the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the… ^{[39][40][41][42][37][38]}

Regulatory snapshot How to read this snapshot

U.S. FDA

1
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Spinal interbody fusion implants

NITRO Interbody Fusion Cage System Family ↗

Cervical and lumbar interbody implant family using silicon nitride. ^[3][4]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Spinal implant systems

Spinal fixation and fusion portfolio ↗

Selected portfolio includes MONET, TAURUS, PICASSO II and MONDRIAN families; individual device mappings remain partial. ^[2]

Marketed · regulatory scope varies

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Activity & Milestones

1 events

2023-04-25 · Regulatory

NITRO interbody family cleared

FDA documented clearance of the NITRO interbody family. ^[4]

60 Cited Sources

Accessed 10/20/2026

[1] Company origins, executives and facilities ↗CTL Amedica · company website

[2] Current spinal portfolio ↗CTL Amedica · company website

[3] NITRO silicon-nitride portfolio ↗CTL Amedica · company website

[4] FDA 510(k) K220513 ↗U.S. Food and Drug Administration · regulatory database

[5] Employer hiring source reviewed ↗CTL Amedica · company website

[6] FDA K073125 — VALEO VBR ↗U.S. Food and Drug Administration · regulatory record

[7] FDA K050699 — MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 ↗U.S. Food and Drug Administration · regulatory record

[8] FDA K161405 — Valeo II Interbody Fusion Device System ↗U.S. Food and Drug Administration · regulatory record

[9] FDA K051525 — ARX SPINAL SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[10] FDA K082037 — SEEPLATE CERVICAL PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[11] FDA K073505 — MODIFICATION TO VALEO VBR ↗U.S. Food and Drug Administration · regulatory record

[12] FDA K142347 — Amedica Valeo II Interbody Fusion Device ↗U.S. Food and Drug Administration · regulatory record

[13] FDA K173453 — Valeo® C+CSC with Lumen Interbody Fusion Device ↗U.S. Food and Drug Administration · regulatory record

[14] FDA K220513 — NITRO Interbody Fusion Cage System Family ↗U.S. Food and Drug Administration · regulatory record

[15] FDA K162682 — MATISSE Anterior Cervical Interbody Fusion Cage System ↗U.S. Food and Drug Administration · regulatory record

[16] FDA K121892 — PHANTOM PLUS CERAMIC CAGE SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[17] FDA K172212 — MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK ↗U.S. Food and Drug Administration · regulatory record

[18] FDA K162160 — Preference Elite Pedicle Screw System ↗U.S. Food and Drug Administration · regulatory record

[19] FDA K231359 — RODIN Expandable Lumbar Cage System ↗U.S. Food and Drug Administration · regulatory record

[20] FDA K091278 — VALEO SPACER SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[21] FDA K172788 — MONET Anterior Cervical Interbody Fusion Cage System ↗U.S. Food and Drug Administration · regulatory record

[22] FDA K073430 — VALEO PEDICLE SCREW SPINAL SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[23] FDA K220334 — MONET Anterior Cervical Plate System ↗U.S. Food and Drug Administration · regulatory record

[24] FDA K231715 — MONDRIAN Anterior Lumbar Plate System ↗U.S. Food and Drug Administration · regulatory record

[25] FDA K072022 — VALEO PEDICLE SCREW SPINAL SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[26] FDA K182151 — MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate ↗U.S. Food and Drug Administration · regulatory record

[27] FDA K213641 — MONDRIAN ALIF Cage with Supplementary Fixation Plate ↗U.S. Food and Drug Administration · regulatory record

[28] FDA K143518 — Valeo Spacer System and Valeo II Interbody Fusion Device System ↗U.S. Food and Drug Administration · regulatory record

[29] FDA K211785 — CASSATT SIJ Fixation System ↗U.S. Food and Drug Administration · regulatory record

[30] FDA K192863 — MONDRIAN Lumbar Interbody Fusion Cage System ↗U.S. Food and Drug Administration · regulatory record

[31] FDA K022729 — VENTED CEMENT RESTRICTOR ↗U.S. Food and Drug Administration · regulatory record

[32] FDA K173185 — SEURAT Universal Pedicle Screw System ↗U.S. Food and Drug Administration · regulatory record

[33] FDA K213491 — Universal Pilot Guidance Instrument System ↗U.S. Food and Drug Administration · regulatory record

[34] FDA K071990 — VALEO CERVICAL PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[35] FDA K233947 — KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System ↗U.S. Food and Drug Administration · regulatory record

[36] FDA K142264 — Valeo C Spacer System, Valeo II C IBF Device ↗U.S. Food and Drug Administration · regulatory record

[37] FDA recall Z-1030-2019 — CTL Medical Corporation ↗U.S. Food and Drug Administration · regulatory record

[38] FDA recall Z-1031-2019 — CTL Medical Corporation ↗U.S. Food and Drug Administration · regulatory record

[39] FDA recall Z-2501-2020 — CTL Medical Corporation ↗U.S. Food and Drug Administration · regulatory record

[40] FDA recall Z-2502-2020 — CTL Medical Corporation ↗U.S. Food and Drug Administration · regulatory record

[41] FDA recall Z-2503-2020 — CTL Medical Corporation ↗U.S. Food and Drug Administration · regulatory record

[42] FDA recall Z-2504-2020 — CTL Medical Corporation ↗U.S. Food and Drug Administration · regulatory record

[43] FDA K131981 — CEZANNE II INTERBODY FUSION SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[44] FDA K140219 — PICASSO II MIS SPINAL SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[45] FDA K121569 — MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[46] FDA K082801 — PHANTOM PLUS CAGE SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[47] FDA K121567 — ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[48] FDA K132365 — SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION ↗U.S. Food and Drug Administration · regulatory record

[49] FDA K120714 — PICASSO MIS SPINAL FIXATION SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[50] FDA K121078 — VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[51] FDA K081296 — PREFERENCE PEDICLE SCREW SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[52] FDA K121568 — DALI SPINAL FIXATION SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[53] FDA K121136 — RENOIR POSTERIOR CERVIAL FIXATION SYSTEM ↗U.S. Food and Drug Administration · regulatory record

[54] Home - CTL Amedica close menu icon ↗CTL Amedica · company website

[55] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record

[56] FDA PMA database — research search ↗FDA / openFDA · regulatory record

[57] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[58] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[59] FDA UDI database — research search ↗FDA / openFDA · regulatory record

[60] FDA De Novo database — research search ↗FDA / openFDA · regulatory record