Curated for Orthogate.org Members

CLINICAL OVERVIEW

Bioretec Ltd. has received FDA 510(k) clearance (K261057) for its innovative ActivaScrew™ Cannulated COM, an advanced bioabsorbable compression screw engineered for trauma, extremity reconstruction, and sports medicine fixation. Utilizing proprietary poly-lactic-co-glycolic acid (PLGA) polymer technology, the headless cannulated implant provides rigid initial mechanical stability while undergoing programmed bio-resorption over approximately two years, eliminating secondary hardware removal procedures.

Secondary implant removal surgeries represent up to 15% to 20% of elective extremity procedures, carrying associated surgical risks, soft-tissue disruption, and financial costs. The ActivaScrew™ Cannulated COM directly counters this clinical burden through Bioretec's patented Auto-Compression™ technology. Under in-vivo physiological conditions, the polymer molecular orientation causes the screw to expand 1% to 2% in diameter while shortening in length, maintaining continuous dynamic compressive loading across the fracture or osteotomy interface during early bone healing.

Its headless design ensures the proximal screw margin rests countersunk flush with articular cartilage or cortical bone, preserving adjacent soft tissue gliding planes and avoiding tendon irritation. The PLGA copolymer undergoes controlled hydrolytic degradation into naturally metabolized lactic and glycolic acids, completely replaced by native bone over approximately 24 months without osteolysis.

REGULATORY & EVIDENCE PATHWAY

• Regulatory Basis: The FDA cleared K261057 based on comprehensive biomechanical fatigue testing, torsional yield evaluations, pull-out strength metrics, and biocompatibility assays adhering to ISO 10993 standards.
• Supporting Evidence: Degradation kinetics confirm sustained mechanical shear and bending strength throughout the critical initial 8–12 week osteosynthesis period, followed by hydrolytic breakdown into harmless lactic and glycolic acids metabolized via the Krebs cycle and replaced by native trabecular bone over a 24-month span.
• Key Data Points: Bench testing and dynamic load evaluations confirmed continuous interfragmentary compression throughout bone union, overcoming the progressive fixation relaxation typical of older-generation bioresorbable screws.

SURGICAL WORKFLOW IMPACT

Packaged sterile for immediate operating room deployment, the cannulated design facilitates accurate guidewire placement under fluoroscopic control. Standard hex/torx driving interfaces ensure intuitive handling for orthopaedic trauma and foot & ankle surgeons without unfamiliar instrumentation or proprietary driver systems.

Eliminating secondary hardware removal surgeries frees operative capacity and decreases patient morbidity in high-volume ambulatory surgical centers (ASCs). Outpatient centers benefit from reduced revision rates, lower sterile processing turnover requirements, and high patient satisfaction associated with bioresorbable implants.

COMPETITIVE LANDSCAPE

The ActivaScrew™ Cannulated COM competes in the resorbable fixation market against bioabsorbable offerings from Stryker, Arthrex, and Wright Medical/Tornier, as well as metallic headless compression screws (such as Herbert screws and Synthes HCS). Traditional metallic implants provide rigid fixation but frequently cause cold intolerance, hardware prominence, and painful tendon friction requiring removal.

The primary differentiator is the active dynamic Auto-Compression™ capability, which counteracts common resorbable implant pitfalls such as loss of compression during polymer relaxation. Furthermore, the bioabsorbable PLGA formulation avoids the chronic sterile foreign-body osteolysis historically seen with pure PLLA polymers.

CLINICAL SIGNIFICANCE FOR ORTHOGATE MEMBERS

For extremity and trauma surgeons, the ActivaScrew™ Cannulated COM provides an optimal balance of robust primary fixation and biological resorption. The ability to achieve active dynamic compression without permanent metallic foreign bodies is especially advantageous in peri-articular fractures, scaphoid fixations, hallux valgus osteotomies, and pediatric or young active populations where hardware irritation is prevalent.

Sources:

• OrthoSpineNews: Bioretec Receives FDA 510(k) Clearance for ActivaScrew™ Cannulated COM
• FDA 510(k) Premarket Notification Database (K261057)