| K-number | K250712 |
| Device name | Linkt Compression Staple System |
| Applicant | Trax Surgical |
| Product code | JDR |
| Device class | Class II |
| Decision date | May 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Linkt Compression Staple System is a bone fixation device made from nickel-titanium alloy (Nitinol) consisting of sterile staple implants and single-use surgical instruments. It is intended for fracture and osteotomy fixation and joint arthrodesis procedures in the hand and foot, with staples available in sizes ranging from 9mm x 9mm to 20mm x 20mm.
The device is manufactured from Nitinol (ASTM F2063) with chemical etching and passivation to form a protective oxidation layer. It shares the same material composition and serrated gripping features on the staple legs as the predicate devices. Both the subject device and primary predicate are sterilized by gamma irradiation.
Pull out Strength Testing (ASTM F564), Static 4 Point Bend Testing (ASTM F564), Dynamic 4 Point Bend Testing (ASTM F564), Corrosion Susceptibility Testing (ASTM F2129), and Radio-Frequency Induced Heating (ASTM F2182).
The Linkt system demonstrates substantial equivalence because it uses identical Nitinol material (ASTM F2063) with the same serrated gripping design as the predicates, maintains the same operational principle for bone fixation, and passes the same performance testing standards across strength, bend, corrosion, and heating parameters. The identical sterilization method (gamma irradiation) and comparable indications for use in hand and foot fixation further support equivalence without raising new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov