Since the beginning of the year, Becker's Spine Review has reported on 48 spine device companies that received FDA clearances, launched new products, expanded operations and agreed to acquisitions:
Contact Alan Condon at acondon@beckershealthcare.com to add medical device news for spine to this list.
July
1. 7D Surgical achieved CE Mark certification for its Machine-vision Image Guided Surgery system for spine surgery.
2. Empirical Spine completed enrollment for a clinical trial exploring the use of its LimaFlex Paraspinous Tension Band.
3. Intralink-Spine expanded clinical trials of its Rejuve device in Australia.
4. Ulrich Medical USA launched its Momentum posterior spinal fixation system.
5. Life Spine began a clinical trial of its Prolift Lateral Expandable system. The company also received FDA clearance for its Lateral Prolift Expandable System and Prolift Lateral Fixated System in March and April respectively.
6. Happe Spine's PEEK technology was awarded a patent from the U.S. Patent and Trademark Office.
7. Spinal Elements' Sapphire X anterior cervical fixation system received FDA clearance.
8. Joimax bolstered its presence in the Australian market through a partnership with medical device distributor LifeHealthcare.
June
9. Augmedics launched its Xvision Spine System, an augmented reality device for surgical procedures.
10. NuVasive launched Reline 3D, a posterior fixation system for pediatric spinal deformities. In March, a study published in Spine showed NuVasive's Attrax Putty to be an effective bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion. NuVasive's Modulus ALIF and Cohere TLIF-O implants also received FDA approval in May.
11. SeaSpine launched its Mariner MIS and Mariner Outrigger spinal fixation systems.
12. Xenco Medical launched CancelleX, a porous titanium lumbar interbody system.
13. CoreLink received FDA clearance for its F3D-C2 standalone cervical spine system.
14. Icotec ag received approval for its Kong-TL and Kong-C vertebral body replacements in the U.S. and Europe.
15. MiRus received FDA clearance for its 3DR Printed Lumbar Interbody Fusion system.
16. OrthoPediatrics launched the ApiFix minimally invasive deformity correction system.
17. The FDA granted 4WEB Medical clearance for its Stand-Alone Anterior Lumbar Interbody Fusion Device.
18. Nexxt Spine's anterior lumbar interbody fusion and lateral implant systems received FDA clearance.
May
19. Precision Spine launched its Reform Ti HA coated pedicle screw system. In April, the company launched its ShurFit ACIF 2C Anterior Cervical, TLIF 2C Interbody Fusion and TPLIF 2C Posterior Interbody systems, as well as Reform MC, a posterior lumbar fusion system.
20. Zavation Medical Products launched eZspand, an expandable lumbar interbody fusion device.
21. Nevro achieved CE mark approval for its Senza Omnia spinal cord stimulation system.
22. Ocutrx Vision Technologies unveiled its OR-Bot Surgery Visualization Theatre for spine and neurosurgery.
23. HD LifeSciences achieved FDA clearance for its Hive anterior lumbar interbody fusion system.
24. Camber Spine launched the Spira-C integrated interbody system and the Fortico anterior cervical plating system.
25. Safe Orthopaedics entered into exclusive negotiations to acquire LCI Medical, which supplies device manufacturers in the spine surgery market.
26. Astura Medical's El Capitan anterior lumbar interbody fusion system received FDA clearance.
April
27. The FDA approved Centinel Spine's prodisc L lumbar total disc replacement device for two-level indications.
28. TDi received FDA clearance for its SonoVision ultrasound system for spine surgery.
29. OrthoPediatrics enhanced its spinal deformity portfolio with the acquisition of ApiFix. In March, the FDA granted the company clearance to expand the indications of its Response Scoliosis system.
March
30. Nexxt Spine launched its Matrixx corpectomy system for spine surgery.
31. The FDA awarded AgNovos Healthcare's AGN1 Local Osteo-enhancement Procedure small volume kit breakthrough device designation.
32. Kuros Biosciences was granted a patent for the use of parathyroid hormone containing matrices for spinal fusion.
33. Medacta received FDA clearance for its Mecta-C Stand Alone anterior cervical fusion device.
34. Biogennix received FDA clearance for an expanded indication of its Agilon moldable bone grafting product.
35. DiscGenics finished enrollment for its clinical trial of IDCT, an allogeneic, injectable disc cell therapy for degenerative disc disease.
36. The FlareHawk expandable cage, developed by Integrity Implants, demonstrated efficient fusion rates in a retrospective study.
37. The AO Foundation and Icotec partnered to develop a spinal stabilization system using the company's carbon/PEEK composite implant material.
February
38. Zimmer Biomet's Mobi-C cervical disc exceeded 150,000 implants worldwide.
39. Genesys Spine launched its Sacroiliac Joint Fusion System for lateral and posterior approaches to sacroiliitis.
40. Additive Implants received FDA clearance for its SureMAX-X cervical spacer.
41. Medicrea gained FDA clearance for its UNiD IB3D patient-matched interbody cages. The company's UNiD Adaptive Spine Intelligence software for spine surgery exceeded 5,000 cases in February.
42. Tenon Medical completed the first phase of its clinical trial for the Catamaran sacroiliac joint fixation system, which found a greater than 85 percent reduction in sacroiliac joint pain at six weeks.
43. Inspan's interspinous fixation device demonstrated positive results in a five-year follow-up study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis.
44. Alphatec announced that it will acquire EOS imaging.
45. Orthofix signed an asset purchase agreement with German company Wittenstein SE to acquire its Fitbone platform, which has potential applications for early onset scoliosis.
January
46. Medtronic acquired Stimgenics, developer of the Differential Target Multiplexed spinal cord stimulation therapy.
47. Atlas Spine launched its V3 Guided Segmental Plating System.
48. Cutting Edge Spine introduced its EVOLha-DLIF direct lateral interbody fusion system.