ZSFab
Medical device company developing patient‑matched, 3D‑printed metallic orthopedic and spinal implants. The organization integrates proprietary lattice‑design algorithms, surgical planning software, metal additive manufacturing (SLM), and post‑processing to produce porous titanium implants with controlled porosity and surface micro/nano‑texture. The company states GMP manufacturing capability, FDA 510(k) clearances for cervical and lumbar interbody systems, and offers design, validation, testing, regulatory, and contract manufacturing services.
Industries
Nr. of Employees
medium (51-250)
Patents
Methods of manufacturing and designing a lightweight femoral stem for hip implants
US-10813766-B2
View Details
Methods of manufacturing and designing a lightweight femoral stem for hip implants
US-10813766-B2
View DetailsProducts
Porous titanium spinal interbody system (cervical and lumbar cages)
3D‑printed titanium interbody fusion cages featuring open porous lattice architectures (reported 70%–80% porosity), surface micro/nano texture, and design features to reduce stiffness mismatch, support bone ingrowth and enable radiographic assessment.
Patient‑matched orthopedic implants (vertebral body, acetabular/triflange cups, hip implants)
Customized metal implants generated from algorithmic design workflows for patient anatomy and mechanical needs, including large central graft windows and adjustable internal shells for strength and fatigue life.
Porous titanium spinal interbody system (cervical and lumbar cages)
3D‑printed titanium interbody fusion cages featuring open porous lattice architectures (reported 70%–80% porosity), surface micro/nano texture, and design features to reduce stiffness mismatch, support bone ingrowth and enable radiographic assessment.
Patient‑matched orthopedic implants (vertebral body, acetabular/triflange cups, hip implants)
Customized metal implants generated from algorithmic design workflows for patient anatomy and mechanical needs, including large central graft windows and adjustable internal shells for strength and fatigue life.
Services
Patient‑matched implant design and surgical planning services integrating imaging data, design optimization, and manufacturing preparation.
Production of 3D‑printed titanium implants under GMP conditions, including printing, post‑processing, inspection, and sterile packaging for clinical use.
Services covering mechanical testing, process validation, preclinical testing support, and assistance with regulatory submissions and quality system implementation.
Patient‑matched implant design and surgical planning services integrating imaging data, design optimization, and manufacturing preparation.
Production of 3D‑printed titanium implants under GMP conditions, including printing, post‑processing, inspection, and sterile packaging for clinical use.
Services covering mechanical testing, process validation, preclinical testing support, and assistance with regulatory submissions and quality system implementation.
Expertise Areas
- Spinal implant design and development
- Additive manufacturing for implantable devices
- Patient‑specific/custom implant workflows
- Regulatory compliance for medical devices (FDA 510(k), ISO 13485, QSR)
Key Technologies
- Metal additive manufacturing (Selective Laser Melting)
- Triply periodic and other engineered lattice architectures
- Topology and lattice optimization algorithms
- Finite element analysis (FEA) and CAE
News & Updates
Announcement of FDA 510(k) clearance for a 3D‑printed cervical interbody system manufactured using SLM Ti‑6Al‑4V ELI.
Announcement of FDA 510(k) clearance for 3D‑printed lumbar interbody cages (PLIF and TLIF) with TPMS porous structures and sterile provision.
Reported first U.S. clinical use of the 3D‑printed lumbar interbody system.
Report of a multi‑level ACDF using a hyperlordotic cervical cage design incorporating TPMS lattice and nano‑surface technology with reported lordosis correction.
FDA 510(k) clearances obtained for cervical and lumbar 3D‑printed interbody systems.
Announcement of FDA 510(k) clearance for a 3D‑printed cervical interbody system manufactured using SLM Ti‑6Al‑4V ELI.
Announcement of FDA 510(k) clearance for 3D‑printed lumbar interbody cages (PLIF and TLIF) with TPMS porous structures and sterile provision.
Reported first U.S. clinical use of the 3D‑printed lumbar interbody system.
Report of a multi‑level ACDF using a hyperlordotic cervical cage design incorporating TPMS lattice and nano‑surface technology with reported lordosis correction.
FDA 510(k) clearances obtained for cervical and lumbar 3D‑printed interbody systems.