Companies / SINTX Technologies

Medical device company profile

SINTX Technologies

Silicon-nitride biomaterials platform expanding from OEM supply into proprietary surgical implants.

Biomaterials Supplier & Medical Device ManufacturerOrthopedics & MusculoskeletalFoot & AnkleInitial implant commercialization and biomaterials platform development

Headquarters🇺🇸Salt Lake City, Utah, United States

FoundedNot confirmed

Commercial statusLimited commercializationCommercial materials/OEM activities plus initial clinical commercialization of the SINAPTIC wedge system; other biomaterial applications remain in development.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitesintx.com ↗

Company overview

SINTX Technologies develops and manufactures silicon-nitride materials and medical-device technologies. Its platform spans monolithic ceramics, composites, coatings and prospective textile applications, with OEM and private-label opportunities alongside a growing direct surgical-device business.

The company acquired SiNAPTIC surgical assets in 2025 and now markets the SINAPTIC Foot & Ankle Osteotomy Wedge System. FDA’s K252254 record names Sinaptic Surgical; the company’s later disclosures connect that acquired program to SINTX and report the first human procedure in March 2026.

Eric Olson is CEO and Chairman and Ryan Elmore is President. SINTX should therefore be understood as both a materials supplier and an emerging implant manufacturer. Uncommercialized material formats and laboratory antipathogenic findings are not treated as cleared clinical claims for every planned application.

^{[28][29][30][31][32][33][34]}

Leadership

4 people

Eric K. OlsonChief Executive Officer & Chairman ^[34]

Ryan ElmorePresident ^[34]

Kevin TraskChief Financial Officer ^[34]

Lisa Marie Del ReChief Commercial Officer ^[28]

Products & regulatory status How does MedTechIndex get this information?

Summary

SINTX’s SINAPTIC foot-and-ankle osteotomy wedge has a matched 510(k) decision and a company-reported limited commercial release. Earlier Amedica orthopedic decisions are preserved as legacy history, separate from the current biomaterials portfolio and from unrelated Amedica Biotech drug tests. ^{[33][35][29][30][12][11][32][28][1]}

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. ^[26][24]

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.

Silicon-nitride osteotomy wedges

SINAPTIC Foot & Ankle Osteotomy Wedge System ↗

Acquired SiNAPTIC Surgical implant program; FDA applicant named Sinaptic Surgical. ^[33][35][29]

FDA-cleared

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

Commercial development

Dual supplier/manufacturer role. One cleared implant family is distinguished from the broader materials and textile pipeline. ^{[33][35][29][30]}

OEM biomaterial and development platform

Silicon-nitride biomaterials / SiNERGY platform ↗

Materials and composites for OEM integration; individual resulting devices require their own regulatory assessment. ^[33]

Investigational / in development

Existing materials/OEM activities coexist with development-stage composite and textile applications.

Activity & Milestones

2 events

2026-03-13 · Commercialization

First SINAPTIC human procedure reported

Company reported the first procedure on March 13, 2026. ^[29]

2025-10-17 · Regulatory

SINAPTIC wedge system cleared

FDA recorded clearance under Sinaptic Surgical; SINTX disclosures establish the acquired program relationship. ^[35]

35 Cited Sources

Accessed 10/20/2026

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

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

[3] FDA K041625 — LTD POLYAXIAL FIXATION SYSTEM ↗U.S. Food and Drug Administration · regulatory record

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

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

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

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

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

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

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

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

[12] FDA K081883 — MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM ↗U.S. Food and Drug Administration · regulatory record

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

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

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

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

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

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

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

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

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

[22] FDA K252254 — Osteotomy Wedge System ↗U.S. Food and Drug Administration · regulatory record

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

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

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

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

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

[28] Investor management team ↗SINTX Technologies · company website

[29] First human procedure and business transformation ↗SINTX Technologies · company website

[30] Mid-year 2026 corporate update ↗SINTX Technologies · company website

[31] Employer hiring source reviewed ↗SINTX Technologies · company website

[32] Active role: Quality Control Technician ↗SINTX Technologies · company website

[33] Materials and medical-device portfolio ↗SINTX Technologies · company website

[34] Current executive team ↗SINTX Technologies · company website

[35] FDA 510(k) K252254 ↗U.S. Food and Drug Administration · regulatory database