OrthoPediatrics儿童股骨逆行钉系统获FDA 510(k)许可：首例手术已完成，2027年全面商业化
总部位于美国印第安纳州 Warsaw 的儿童骨科公司 OrthoPediatrics（纳斯达克：KIDS）10月27日宣布，其儿童钉平台（PNP）新增的股骨逆行钉系统（PNP | Femur Retrograde）已获得美国食品药品监管局（FDA）510(k) 许可，使用该系统的首例手术已经完成。
该系统与一组儿童骨科外科医生合作开发，专为儿童解剖结构设计，以填补一项尚未被满足的临床需求：其中解剖型钉用于创伤治疗，直钉用于畸形矫正。它承接该公司此前推出的 PNP Femur 与 PNP Tibia 产品，并沿用现有 PNP 器械。新系统配有专门器械，意在简化复杂的内翻/外翻与冠状面/矢状面矫正手术。
公司高管 Joe Hauser 表示：「我们的儿童钉平台已在全球支持近15,000名患者。FDA 对 PNP Retrograde 的许可扩展了我们的产品组合，让更多儿童用上专为其需求设计的植入物；首例手术已经完成，我们对这款平台新成员的初步应用感到鼓舞。」
PNP Retrograde 两种钉型的直径均为7毫米至11毫米。该系统将在2026年余下时间限量上市，2027年全面商业化。
OrthoPediatrics 成立于2006年，是专注于儿童骨科的公司，现有95多个系统，覆盖创伤与畸形、脊柱侧弯、运动医学与其他手术三大领域，产品销往美国及75多个国家和地区。
OrthoPediatrics Wins FDA 510(k) Clearance for PNP Femur Retrograde Nail System: First Procedures Completed, Broader Commercialization in 2027
OrthoPediatrics Corp. (Nasdaq: KIDS), a pediatric orthopedics company based in Warsaw, Indiana, announced on October 27 that the Pediatric Nailing Platform (PNP) | Femur Retrograde Nail System (PNP Retrograde) has received U.S. Food and Drug Administration (FDA) 510(k) clearance, and that the first procedures using the system have been completed.
Developed in collaboration with a team of pediatric orthopedic surgeons, the system was designed specifically for pediatric anatomy to address an unmet market need. It includes anatomic nails for trauma and straight nails for deformity, builds on the company's earlier PNP Femur and PNP Tibia launches, and leverages existing PNP instrumentation. New instruments are intended to help simplify complex varus/valgus and coronal/sagittal plane correction procedures.
“Our Pediatric Nailing Platform has supported nearly 15,000 patients worldwide,” said Joe Hauser. “The FDA clearance of PNP Retrograde expands our portfolio and creates an opportunity to reach more children with implants designed specifically for their needs. With the first surgical case already complete, we are encouraged by the initial adoption of this latest addition to our platform.”
PNP Retrograde is available in diameters ranging from 7 mm to 11 mm in both nail designs. The system will be available through a limited market release for the remainder of 2026, with broader commercialization planned for 2027.
Founded in 2006, OrthoPediatrics focuses exclusively on pediatric orthopedics. It markets more than 95 systems across trauma and deformity, scoliosis, and sports medicine and other procedures, distributed in the United States and more than 75 countries.
来源：GSM·美国（原文链接）
图片来源：股骨髓内钉内固定术后影像（资料图，非本产品、非儿童病例）。Hellerhoff 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / Postoperative imaging of femoral intramedullary nail fixation (file photo; not the product in this story and not a pediatric case). Hellerhoff, CC BY-SA 4.0, via Wikimedia Commons.
