Joimax announced that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in order to market their Endoscopic Lumbar Interbody Fusion (EndoLIF® On-Cage implant) in the U.S.

Oxford Performance Materials announced that they have received 510(k) clearance from the FDA for their 3D printed SpineFab VBR System Implants, marking the first ever 3D printed polymer, load-bearing device for implantation that has received FDA clearance.

The FDA cleared a 510(k) for the use of DENTCA’s new 3D printable material as a denture base, the first such approval in the denture production space. 

Titanium based digital fusion of bones of extremities is the first product of Additive Orthopaedics to receive FDA 510(k) clearance. The Limited Liability Company, Additive Orthopaedics, is seeing this oppurtunity as future of surgeries as the 3D Printing Market continues to expand globally.

Scientists are now working with Computer simulation and 3D Printing to develop faster and safer ways of testing medical devices without actually installing them in live humans. Since these medical devices for heart and vascular diseases will be tested on 3D Printed models, the long list of Animal testing, Clinical trials and FDA approval will be surpassed.

FDA has issued draft guidance for 3D printed medical devices which includes recommendations for testing and characterisation. However, Regulatory Affairs Professionals Society (RAPS) added- “FDA says the guidance is not intended to address 3D printed products containing biologics, cells or human tissues" but FDA waits for public comments.

Medicrea, announced FDA approval of the first-ever patient-specific UNiD™Cervical rod for spine surgery, secured by their complementary PASS OCT® posterior cervical stabilization system. Being the only medical device company offering patient-specific implant solutions for spinal conditions, it rolled out it's first implantation of the UNiD™ Patient-Specific Cervical Rod in New York City on February 17,2016.

In the 50 Most Innovative Companies in World 2016, Fast Company has named Oxford Performance Materials in the list for their SpineFab® VBR implant system. It received 510(k) clearance from the FDA in July of 2015. OPM also provides third parties with contract manufacturing services for a wide spectrum of 3D printed biomedical implant applications.

Researchers at University of North Carolina and North Carolina State University have developed a Prosthetic Implant that can be fitted as per amputee requirement and timing. These implants need t conform to patient's specific anatomy and require 12 month rehabilitation. However, FDA has not approved implanted prosthetic sockets for general use; but only for research purposes.

Zimmer Biomet Holdings, a global leader in musculoskeletal healthcare received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Unite3D™ Bridge Fixation System. It is a 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery and includes an osteo-conductive matrix designed to provide for biological incorporation.

BioArchitects announced today the 510(k) clearance by the U.S. Food and Drug Administration – FDA, for the company’s 3D printed patient specific titanium cranial/craniofacial plate implant. Starting from CT scan or MRI of the affected area, the image is then imported into a highly sophisticated computer design program, which is used to create a template of the repair that becomes the model from which the 3D printer produces the titanium plate which is the exact fit for the defect.

Additive Orthopaedics, company specializing in additively manufactured surgical solutions, recently announced that it has successfully treated a series of patients suffering from painful hammertoes with its 3D printed hammertoe implant, which was recently cleared by FDA. While Greg Kowalczyk, President and Founder of Additive Orthopaedics, believes it was only possible with 3D Printing, he stated company is expected to get good response.

The FDA issued draft guidance on 3D-printed devices in May and has already cleared 85 medical devices and one prescription drug manufactured via 3D printing. The guidance has been open for comments until August while the officials note the rules stop short of addressing products that involve biological material.

With recently getting the clearance from US FDA for O2VentTM Mono device, Oventus Medical has now successfully registered its listing on the ASX on 19 July 2016 with a fully subscribed IPO. The company’s O2VentTM  range incorporates an airway to bypass nasal, soft palate and tongue obstructions. The company has also registered its next generation O2VentTM T titratable device with the Australian Therapeutic Goods Administration (TGA) and launched the device for consumers through an expanded network of dentists.

The Texas-based 4Web Medical Company has just announced that they received FDA clearance for their Lateral Interbody Fusion Devices. The platform consists of the Cervical Spine Truss System, the ALIF Spine Truss System, the Posterior Spine Truss System and the Osteotomy Truss System.  4WEB is currently developing truss implant designs for knee, hip, trauma and patient specific procedures where the patient will benefit from optimal porosity and osseous incorporation.

Since the launch of less costly 3D Printers, more and more users are now getting to 3D Print their own Pharmaceutical pills at home. This has led to Piracy issues of 3D Printed medical drugs which require FDA approval and hence, the need to claim copyrighting for them. It has been asked that manufactures might be required to design the drugs in such a way that it requires a specific type of material, one not compatible with 3D technology.

Syqe Medical, an Israeli drug delivery company has introduced a 3D Printed Medical Marijuana Inhaler which can deliver metered doses of cannabis or weed, thereby providing a controlled treatment. The inhaler will be free of smoke or other carcinogenic materials, and is expected to be distributed by Teva Pharmaceuticals, once the FDA approval is gained next year.

Before 3D Printing Medical Devices can be used for clinical applications, they must first get approval from FDA. On December 4, 2017, the FDA issued a guidance to help speed up the approval process for companies seeking the approval. Additionally, there were Research and Development tax credits that a company can seek to offset 4-7% of the cost associated with testing, process improvement, and production. To receive the research and development benefits, the company must meet the four eligibility criteria set up.

Two companies recently announced that they have received (510)k clearance from the US Food and Drug Administration (FDA) for 3D printed titanium spinal implants. While Camber Spine Technologies from Pennsylvania received FDA clearance for its SPIRA Open Matrix ALIF device, an interbody fusion implant; the other one was Renovis Surgical Technologies from California for its posterior lumbar Tesera porous titanium interbody fusion systems.

Emerging Implant Technologies (EIT), a German company, famous for its Cellular Titanium technology, has received FDA clearance again, to expand their EIT Cellular Titanium Cervical Cage to be used in multiple contiguous cervical levels (C2 to T1) and this is the first multi-level 3D printed cervical cage to enter the US market. It is designed to be used with autogenous and/or allogenic bone grafts to facilitate fusion, and should be used with supplemental fixation.

Florida-based Captiva Spine Inc., a privately owned medical device organization that was founded in 2007 has recently received 510(k) clearance from the FDA for its 3D Printed TirboLOX-L Titanium Lumbar Cages. TirboLOX-L Titanium Lumbar Cages uses 3D printing to form interbody fusion devices, made out of titanium alloy, with a double layer organic lattice structure and include the benefits such as the bone’s ability to successfully grow within its architecture, which can then help it achieve good kinematic properties.

Local company BioArchitects was founded by young entrepreneur, Felipe Marques four years ago with investment in medical 3D Printing to harvest the technology. The company now uses metal 3D printing technology to create patient-specific, biocompatible implants that replace hard tissue and allows doctors to actually be able to see and manipulate a replica of what they will find when they operate. The BioArchitects also performs in field of medical training, simulated operations and prosthetics, with their titanium plate being first of its kind to be approved for use by the US Food and Drug Administration (FDA).

3D Systems has received FDA 510(k) Clearance for their Biocompatible Dental Material, NextDent Denture 3D+, developed for use on the NextDent 5100 3D printing platform. According to 3D Systems, combination with the NextDent C&B MFH material, which has been designed to print the teeth of a denture, users can save up to 90% in cost and 75% in time for producing the base of denture. The new material also possesses excellent mechanical properties in accordance with ISO Denture Base Standards and the comprehensive colour palette allows dental labs are able to match the printed product to the patient’s gums.