Paragon 28, Inc. · Class II · Cleared Jul 18, 2025
| K-number | K250952 |
| Device name | Baby Gorilla®/Gorilla® Plating System |
| Applicant | Paragon 28, Inc. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Jul 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Baby Gorilla/Gorilla Plating System is a bone fixation device comprising titanium and stainless steel plates, screws, and washers in mini and standard sizes. It is indicated for stabilization and fixation of fractures, osteotomies, joint fusions, and reconstructions in small bones of the foot, ankle, hand, and wrist in both adult and pediatric patients.
The subject device possesses similar technological characteristics to the predicate including performance, basic design, materials (medical-grade titanium per ASTM F67, stainless steel per ASTM F138, and titanium alloy per ASTM F136), manufacturing processes, and comparable dimensions across mini and standard set sizes.
ASTM F67 (medical-grade titanium), ASTM F138 (stainless steel), and ASTM F136 (titanium alloy) are cited for material specifications. Engineering analysis is presented but no other specific consensus standards for performance testing are detailed in this summary.
The subject device uses identical indications for use, materials, and design principles as the predicate Baby Gorilla/Gorilla Plating System (K203511). Differences in the subject device modifications were shown through engineering analysis not to raise new safety or effectiveness questions, and performance testing demonstrated the modified designs are substantially equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov