Pediatric Nailing Platform Femur— 510(k) K261345
Substantially EquivalentOrthoPediatrics Corp.
FDA 510(k) clearance K261345 for Pediatric Nailing Platform Femur, Substantially Equivalent on 2026-09-24. Applicant: OrthoPediatrics Corp.. Device class: 2.
Summary
The Pediatric Nailing Platform (Femur) from OrthoPediatrics Corp. is an intramedullary nail system for the femur in children, filed under HSB, intramedullary fixation rods and accessories. The record doesn't list the nail sizes or specific indications.
Class II, 21 CFR 888.3020. The Orthopedic panel reviewed it as a Traditional 510(k).
OrthoPediatrics filed from Warsaw, Indiana. Review took 154 days (April 23 to September 24, 2026).
Clearance details
- Applicant
- OrthoPediatrics Corp.
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code HSB
view all- K261481 — Pangea Femur Reconstruction System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from OrthoPediatrics Corp.
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.