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Overview

OsteoSinter® EVANS and COTTON wedges are porous titanium implants for Evans osteotomy (lateral column lengthening) and Cotton osteotomy (opening wedge of the medial cuneiform, to improve the inclination of the first ray and avoid overloading the lateral column) in the correction of adult-acquired flatfoot. Eighteen wedge sizes allow the correction to be matched to the osteotomy.

The OsteoSinter® material is biocompatible commercially pure titanium made by powder metallurgy, with 62–66 % interconnected porosity by volume. Each wedge is supplied individually packed in a blister and sterilised by gamma radiation, and is placed with a sterile single-use instrument kit made of polyamide 12. As metallic implants, the wedges are not subject to resorption.

Features

  • Placed directly, without carving or on-site adjustment
  • Sized wedges (12 EVANS, 6 COTTON) for controlled correction
  • Porous structure and textured surfaces for primary fixation to the bone
  • Wedges and instrument kit supplied sterile: no sterilisation or instrument processing required
  • Ancillary fixation at the surgeon’s discretion; the current surgical technique does not recommend it
  • Single-use kit: one sizer for each size and type of wedge, tweezers to hold and insert the wedge, and an impactor used with a standard mallet (not supplied)
  • Material properties (representative values, manufacturer data): elastic modulus 2.8 GPa, compressive yield strength 31 MPa

Indications

Internal osteotomies of the bones of the foot in the correction of adult-acquired flatfoot (stage II posterior tibial tendon dysfunction):

  • lateral column lengthening (Evans osteotomy);
  • opening wedge osteotomy of the medial cuneiform (Cotton osteotomy).

Not intended for use in the spine.

Contraindications

  • Infection.
  • Physiologically or psychologically inadequate patient (limited ability or willingness to restrict activities or follow post-operative instructions).
  • Inadequate skin, bone or neurovascular conditions, which may delay healing.
  • Growing patients with open epiphyses.
  • Foreign-body sensitivity: where material sensitivity is suspected, test before implantation.
  • Smoking may result in delayed healing, non-healing or compromised stability.

See the electronic instructions for use (eIFU) for full information.

Sizes and ordering

For availability, kit contents or a quote, use Enquire above or call us.

OsteoSinter® EVANS wedges — 12 sizes12 items
Ref.NameWidth (mm) [W]Length (mm) [L]Height (mm) [H]
P00209A1OsteoSinter® EVANS wedge 18W × 18L × 6H18186
P00200B1OsteoSinter® EVANS wedge 18W × 18L × 8H18188
P00201B1OsteoSinter® EVANS wedge 18W × 18L × 10H181810
P00202B1OsteoSinter® EVANS wedge 18W × 18L × 12H181812
P00210A1OsteoSinter® EVANS wedge 20W × 20L × 6H20206
P00203B1OsteoSinter® EVANS wedge 20W × 20L × 8H20208
P00204B1OsteoSinter® EVANS wedge 20W × 20L × 10H202010
P00205B1OsteoSinter® EVANS wedge 20W × 20L × 12H202012
P00211A1OsteoSinter® EVANS wedge 22W × 22L × 6H22226
P00206B1OsteoSinter® EVANS wedge 22W × 22L × 8H22228
P00207B1OsteoSinter® EVANS wedge 22W × 22L × 10H222210
P00208B1OsteoSinter® EVANS wedge 22W × 22L × 12H222212
OsteoSinter® COTTON wedges — 6 sizes6 items
Ref.NameLength (mm) [L]Height (mm) [H]
P00300B1OsteoSinter® COTTON wedge 15L × 4.5H154.5
P00301B1OsteoSinter® COTTON wedge 15L × 5.5H155.5
P00302B1OsteoSinter® COTTON wedge 15L × 6.5H156.5
P00303B1OsteoSinter® COTTON wedge 20L × 4.5H204.5
P00304B1OsteoSinter® COTTON wedge 20L × 5.5H205.5
P00305B1OsteoSinter® COTTON wedge 20L × 6.5H206.5

Codes and sizes are taken from the manufacturer's marketing literature and may change. For current information, check the AMES Medical website or the instructions for use before ordering.

OsteoSinter® EVANS and COTTON implants: surgical technique (AMES Medical)

Technical session with Dr Daniel Poggio and Dr Michail Kokkinakis (AMES Medical)

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