Curated for Orthogate.org Members
BAGUERA® C Cervical Disc Prosthesis
Spineart SA — FDA 510(k) Cleared / PMA Approved
| Manufacturer | Spineart SA / Spineart USA, Inc. |
| Device / System | BAGUERA® C Cervical Disc Prosthesis and Surgical Instrumentation |
| Regulatory Status | FDA 510(k) Cleared (K262639) / PMA Approved (P250042) |
| Indications | Cervical artificial disc replacement (C3–C7) in skeletally mature patients for single-level intractable radiculopathy or myelopathy |
| Subspecialty | Spine Surgery / Cervical Arthroplasty |
| Commercial Availability | Full Commercial Launch in the United States |
CLINICAL OVERVIEW
The BAGUERA® C Cervical Disc is a motion-preserving total disc replacement designed to reconstruct the intervertebral disc space following single-level cervical discectomy. Engineered with a mobile ultra-high-molecular-weight polyethylene (UHMWPE) articulating core between two titanium-coated endplates, the implant facilitates controlled physiological flexion-extension, lateral bending, and axial rotation while resisting non-physiological translation.
The titanium endplates feature an anatomical dome contour and a specialized diamond-shaped porous plasma spray coating combined with a central keel for immediate mechanical primary stability and long-term osseointegration. This multi-radius design aims to minimize interfacial shear stresses and preserve native segmental lordosis across C3 to C7 segments.
REGULATORY & EVIDENCE PATHWAY
- Regulatory Basis: FDA Premarket Approval (PMA P250042) supported by 510(k) instrumentation clearance (K262639) establishing substantial equivalence of insertion and trial instruments.
- Supporting Evidence: Prospective, multicenter IDE non-inferiority clinical trials comparing BAGUERA® C to anterior cervical discectomy and fusion (ACDF) demonstrated statistically significant preservation of segmental range of motion, lower rates of adjacent-segment disease, and superior Neck Disability Index (NDI) scores at 24-month follow-up.
- Key Data Points: Composite overall success was superior to control ACDF constructs with a revision/reoperation rate under 2.5% at two years.
SURGICAL WORKFLOW IMPACT
The updated BAGUERA® C surgical instrument set simplifies site preparation with streamlined trialing, rail-guided rasping, and single-step inserter engagement. The guided insertion technique ensures repeatable sagittal midline positioning under fluoroscopy while reducing operative steps compared to legacy modular systems. Operative time is comparable to standard ACDF without requiring anterior plate screw fixation.
COMPETITIVE LANDSCAPE
BAGUERA® C competes directly in the growing motion-preservation market against established cervical arthroplasty platforms including the Medtronic Prestige LP, Centinel Spine prodisc C Vivo, and NuVasive Simplify Disc. Its differentiated semi-constrained mobile-core kinematics and low-profile diamond-keel design appeal to surgeons seeking bone-preserving endplate preparation with reduced heterotopic ossification risk.
CLINICAL SIGNIFICANCE FOR ORTHOGATE MEMBERS
For spine attendings and fellows, BAGUERA® C provides a compelling alternative to fusion in young, active patients with soft-disc herniation or spondylotic radiculopathy. The mobile-bearing core kinematics closely mimic the instantaneous center of rotation of the subaxial cervical spine, reducing stress transfer to adjacent functional spinal units and mitigating adjacent segment breakdown.
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