US EditionMedline announces FDA clearance for REFLEX® HYBRID Nitinol Implants for foot and ankle surgery
- Medline UNITE announced FDA 510 clearance for REFLEX HYBRID Nitinol Implant System on April 16, 2025.
- This clearance allows Medline UNITE to expand its REFLEX portfolio for foot and ankle surgeries.
- The REFLEX HYBRID combines a nitinol staple's compression with a locking plate's stability for fusions and procedures.
- Scott Goldstein stated the product addresses gaps by offering specific designs, compression, and adjustment with nitinol.
- Testing showed the HYBRID implant with a screw provided better load to failure results than traditional methods.
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19 Articles
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Medline announces FDA clearance for REFLEX® HYBRID Nitinol Implants for foot and ankle surgery
Latest launch expands REFLEX® portfolio with additional options to deliver dynamic biplanar compression
Medline Announces FDA Clearance For REFLEX HYBRID Nitinol Implants For Foot And Ankle Surgery
Medline UNITE, a leader in the foot and ankle surgery market, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest implant family, the REFLEX® HYBRID Nitinol Implant System. While nitinol staples have steadily risen in popularity, static plates and screws are widely used in conjunction with staples to provide added fixation and stability. A key disadvantage of such hybrid constructs is …
Medline Announces FDA Clearance For REFLEX HYBRID Nitinol Implants For Foot And Ankle Surgery - Medical Device News Magazine
“REFLEX HYBRID further demonstrates our commitment to offering innovative solutions for foot and ankle surgeons. The first to market product addresses gaps in the current competitive landscape, including offering indication specific designs, intraoperative compression, and intraoperative adjustment with a nitinol implant,” said Scott Goldstein, vice president of product management for Medline UNITE.
Medline announces FDA clearance for REFLEX® HYBRID Nitinol Implants for foot and ankle surgery – Ortho Spine News
Medline UNITE’s REFLEX HYBRID Nitinol Implant System Latest launch expands REFLEX® portfolio with additional options to deliver dynamic biplanar compressionNORTHFIELD, Ill., April 16, 2025 – OrthoSpineNews – Medline UNITE, a leader in the foot and ankle surgery market, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest implant family, the REFLEX® HYBRID Nitinol Implant System. While ni
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