Zfuse osteoconductive peek fda plus#

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, Issued June 2007įDA Technical Contacts Jinrong (Jinny) Development Organization ASTM Guidance for Industry and FDA Staff: Spinal System 510(k)s, Issued May 2004 Unlike interbody fusion devices that are coated, PEEK-OPTIMA TM HA Enhanced devices have hydroxyapatite crystals on all surfaces which results in earlier bone on-growth and greater new bone formation on a fully osteoconductive implant.

Zfuse osteoconductive peek fda plus#

Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems, Issued January 2000 All the benefits of PEEK-OPTIMA TM Natural plus Hydroxyapatite (HA) crystals embedded throughout the material, a well-known osteo-conductive material. Relevant FDA Guidance and/or Supportive Publications* Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, Issued May 1995 Orthosis, Spondylolisthesis Spinal Fixation Public Law, CFR Citation(s) and Procode(s)* Regulation NumberĪppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentĪppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeĪppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentĪppliance, Nail/Blade/Plate Combination, Single Componentĭevice, Fixation, Proximal Femoral, Implant Rationale for Recognition This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.ġ.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices. Indicated properties are for fabricated forms. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.ġ.2 The properties included in this specification are those applicable for PEEK polymers only. Scope/Abstract 1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, fabricated forms, and so forth). Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications In the last four months, Nvision enhanced its portfolio with four FDA approved products, with one currently being reviewed by the FDA and two others scheduled for submission.Part B: Supplementary Information Sheet (SIS)

Its PEEK-OPTIMA HA Enhanced material has a modulus similar to bone and allows artifact-free imaging and provides an osteoconductive surface for bone on-growth, said Nvision.Įstablished in 2013, Nvision is a large-scale medical device manufacturer based in San Antonio, US, with 23 FDA approved devices across different orthopaedic specialities. Trigon Stand-Alone Subtalar Wedge has a 25mm diameter and offers correction heights ranging from 6mm to 16mm in parallel and angled options. In addition, the system comes with a triplanar correction feature, where a jerk allows for frontal plane rotation, along with the ability to restore and maintain the length of the first metatarsal. The wedge is offered in three footprint sizes, with several lengths restoring thicknesses and variations in sagittal and transverse angle correction. The FDA approval indicates Trigon Lapidus Wedge as a PEEK-OPTIMA HA Enhanced implant for a first metatarsal-cuneiform lengthening arthrodesis.Īccording to the company, Trigon Lapidus Wedge is the first implant to specifically reference lengthening in its FDA indication.

“By taking an innovative approach to marrying the best materials, manufacturing platforms, and engineering science, we are changing the conversation around foot and ankle surgery.” Nvision product development senior vice president Tom Zink said: “We are always looking at new ways to address different foot and ankle procedures that will benefit the patient and surgeon. The Lapidus and Subtalar Fusion Wedges, part of the expanded Trigon product line, mark the company’s fifth and sixth medical devices to use PEEK-OPTIMA HA Enhanced. PEEK-OPTIMA HA Enhanced is a spinal device technology used for material enhancement.ĭeveloped by Invibio Biomaterial Solutions, the polymer is said to promote multi-directional bone healing and allows for improved fixation. Nvision Biomedical Technologies has received the US Food and Drug Administration (FDA) approval for the first use of PEEK-OPTIMA HA Enhanced with its Lapidus and Subtalar Fusion Wedges. PEEK-OPTIMA HA Enhanced promotes multi-directional bone healing.

With the FDA approval, Nvision’s expanded Trigon family of Wedge systems will use PEEK-OPTIMA HA Enhanced along with lengthening capabilities