PEEK implant with representation of hydroxyapatite crystals on bone surface

Bioactive material

PEEK-OPTIMATM HA Enhanced

Hydroxyapatite integrated into the PEEK matrix so that the final surface of the device has HA crystals without depending on coating.

Technical view

Bioactivity present throughout the piece

In PEEK-OPTIMA HA Enhanced, hydroxyapatite crystals are dispersed in polymer volume. Thus, surfaces obtained by machining, molding or 3D printing also expose HA, without an external layer subject to delamination.

Bone integration

HA is a calcium phosphate mineral recognized for favoring the apposition and integration of bone tissue.

Clinical image

The radiolucency of PEEK reduces artifacts compared to metals and helps the evaluation of the treated area.

Mechanical performance

The closest modulus to the bone can help reduce the stress shielding in the device design.

Freedom of manufacture

The technology can be worked by machining, molding and additive manufacturing, according to the validated degree and process.

>75% of direct bone contact in 4 weeks in the preclinical sheep study cited

92,2% fusion in 12 months in the observational record of ACDF cited

1.565 segments followed in the multicenter clinical record cited

Preclinical evidence

The source material reports greater formation of new bone and better quality bone bridges in sheep models when compared to PEEK-OPTIMA Natural. Preclinical results should not be interpreted as equivalent to results in humans.

PEEK implant representation integrated to a vertebra

Clinical record in cervical spine

An observational record with 789 patients, 1,565 segments and 20 centers in the United States reported fusion of 91.3% in 6 months and 92.2% in 12 months, as well as improvement in the NDI and VAS indices. Because it is not a controlled trial, the authors themselves recommend additional evaluations.

Mean NDI: 46.3 before surgery and 25.2 in 12 months
Neck VAS: 64.2 before surgery and 28.6 in 12 months
Informed satisfaction: 95.1% in 12 months
Device-related review: 3 patients, or 0.2%

Fields of application

The document presents opportunities in spine, sports medicine, foot and ankle and craniofacial applications. The geometry, process, sterilization and clinical use need to be validated for each device.