BETA
Dallas-based manufacturer of spinal fusion implants, spinal fixation systems and associated surgical instruments.
Osseus Fusion Systems, LLC, trading as Osseus, is a privately held medical-device company based in Dallas, Texas. Its company LinkedIn profile lists a 2012 founding date. The business develops and markets its own spinal fusion and fixation systems.
The current portfolio includes Aries lumbar interbodies, Black Diamond pedicle screw and posterior occipito-cervico-thoracic systems, Blue Topaz sacroiliac screws, Gemini-C cervical interbodies, Pisces-SA and Pisces-SC interbody systems, and White Pearl anterior cervical plates. Selected implants use porous, additively manufactured titanium; materials and fixation requirements vary by device.
Published FDA records document U.S. clearances for the reviewed families and navigation instruments. Current product pages invite distributor inquiries, but recruitment is not an established distribution agreement. Revenue and an independently reconciled current executive roster were not established in the reviewed company sources.
Eleven relevant 510(k) decisions map to the displayed spinal implant families and associated navigation instruments. Successive decisions are retained without treating each clearance as a separate product. Unrelated ARIES diagnostic systems, Medtronic Pisces leads, other Pisces brands and the separate Osseus, LLC OSSE-LIGN applicant are excluded. [2][35][44][42][38][37][43][45][36][41][39][40]
FDA cleared Pisces-SC under K261882 on August 21, 2026. Its cervical indications and standalone use depend on configuration: the two-screw configuration can be standalone, while anchor configurations or use without integrated fixation require supplemental fixation. The manufacturer’s standalone trade name does not override those conditions. [45][31]
Pisces-SA has two reviewed decisions, K213935 and K223413. Other current families include Aries, Gemini-C, White Pearl, Blue Topaz and Black Diamond. These are 510(k) clearances rather than PMA approvals; product marketing does not extend the authorized anatomy, indication or compatibility. [42][44][38][37][36][41][39][43]
Published FDA searches under the company and selected product names found no relevant original PMA approvals, De Novo grants or recall events. Unrelated name matches are excluded. [34][32][33][46]
Latest recorded source review: 2026-10-27.
Documented commercial product families.
Porous titanium interbody implants marketed as Aries-TS, Aries-TC and Aries-L for transforaminal and lateral approaches. [4][38][24]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Pedicle screws, rods and associated instruments for open and minimally invasive fixation; a separate clearance covers navigation instruments. [6][35][21][39][25][40][26]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Screws, rods, connectors and related implants/instruments for posterior cervical and upper-thoracic stabilization. [5][43][29]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Fenestrated, threaded screw system with multiple diameters and lengths. [7][41][27]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Cervical interbody implant combining PEEK with porous titanium features. [8][37][23]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Porous 3D-printed titanium anterior lumbar interbody platform with screw/anchor fixation options and locking plate. [9][44][30][42][28]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Cervical interbody implant with screw/anchor fixation options and locking plate. [10][45][31]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Anterior cervical plates and screws with locking features and multiple plate sizes. [11][36][22]
FDA-clearedCurrently marketed by the U.S. manufacturer; U.S. clearance is documented. Availability in other jurisdictions was not established.
Current product pages invite prospective distributors to contact Osseus. This is an advertised network-development signal, not a verified partner appointment, open employee vacancy or grant of exclusive territory. No current individual job listings were verified in this review. [6][9]
FDA issued a substantial-equivalence decision for the cervical interbody system with configuration-specific fixation requirements. [45]
Accessed 10/27/2026
Last substantive review: 10/27/2026