PeekMed Gains FDA Clearance for Pre-Op Planning Software

By Julie A. Vetalice

PeekMed has received FDA 510(k) clearance to market its previously-CE Marked PeekMed® 3D pre-operative planning software.

PeekMed uses standard imaging (x-ray, CT, MRI) stored in local PACS servers to allow the surgeon to select from a database of implants to select the option most suitable for the patient.

Other PeekMed features include:

  • An intuitive surgical sectioning of a bone in order to correct its deformity. To perform osteotomies, PeekMed includes a wizard and measurement tool specific for each sub-specialty.
  • Cloud-based storage for patient studies, data and reports.
  • 2D/3D hybrid planning capability.

Current OEM partners with PeekMed include Aesculap, Amplitude Surgical, Arthrex, DePuy Synthes, LimaCorporate, Medtronic, MicroPort, Permedica, Smith & Nephew, Wright Medical and Zimmer Biomet.

Source: PeekMed; image courtesy of PeekMed

Product Labels: Surgical Planning

Tags: 510(k) Clearance, Regulatory