ĢƵ

Simplifying
Shoulder Surgery

The ĢƵ™ implant was designed to replace traditional suture anchors that require complex and time-consuming steps and address the shortcomings of suture-based fixation.

ĢƵ represents a completely different approach to rotator cuff repair. Instead of threads cutting through tendon, it uses a small polyether-ether-ketone (PEEK) implant that effectively “staples” the tendon to bone over a broad area. The implant consists of a base plate with teeth on the underside that sits on the tendon surface and small fixation prongs that are driven into bone, clamping the tendon down.

The ĢƵ design is aimed at eliminating the point-loading of sutures—there are no concentrated suture anchor points, and at distributing the pressure is evenly across the repair footprint.

Sinefix
ĢƵ

FDA Cleared

Sinefix Shoulder Surgery System
ĢƵ Traditional

Simple Surgical Technique

  • No knot tying or suture management required
  • One ĢƵ implant can replace multiple suture anchors
  • Expected to reduce surgery time and contribute to cost savings

Improved Tendon to Bone Fixation

  • Higher pull-out forces than double row fixation using less implants
  • Minimizes punctual pressure aiming to reduce risk of loosening post surgery
  • Demonstrates less gap formation than double row fixation to optimize contact pressure

Ensuring blood flow and facilitating healing

  • Gentle contact between tendon and bone aiming to prevent the creation of any acellular, necrotic zones in the tendon
  • Even pressure load over the tendon ensuring good blood circulation
  • Instrumentation designed to prevent excessive compression of tendon

BIOMECHANICAL EVALUATION

In a direct comparison, the new ĢƵ implant had higher pull-out forces and less gap formation than a double-row repair (DRR). 10 fresh sheep infraspinatus tendons were refixed with ĢƵ and DRR (2x medial and 1x lateral all-suture anchor) respectively.

Methodology: after preloading with 10 N, the tendons were cyclically loaded with 10 to 62 N over 200 cycles at 0.2 Hz. The tendons, which were then still refixed, were loaded until they ruptured. View the poster.

Gap Formation:

Gap formation under cyclic loading up to 62 N

Pull Out Strength

All (n=10) tendons refixed with ĢƵ survived cyclic loading up to 62N with a gap formation up to 1.49 millimeter (SD 0.84). In contrast, with the DRR method, one tendon remained less stable (n=9) with a gap formation of 3.19 millimeters (SD 0.91) (p=0.001).

Pullout Strength:

Pullout forces

Pull Out Strength

The maximum pullout forces with ĢƵ (n=6) were 215N (SD 55) versus DRR (n=4) with 166N (SD 15) (p=0.084).

CAUTION: ĢƵ is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm. U.S. Federal law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device. ĢƵ is not approved for sale outside the U.S.

Designed to address challenges with rotator cuff repair surgery

Learn more about ĢƵ and thethree main challenges with rotator cuff repair surgery it addresses.

Patient Outcomes

Current gold standard used for decades without significant improvement in patient outcomes

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Suture Anchors

Use of suture anchors in arthroscopic RCR involves complex surgical technique

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Retears

Postoperative rotator cuff retear after rotator cuff repair is still a major problem

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