# OrthoPediatrics Corp.

- Location (FDA's records): Warsaw, IN
- FDA decisions: 45 (2008–2026): 45 510(k) clearances
- Names in FDA's records: OrthoPediatrics Corp. (41); Orthopediatrics, LLC (2); Orthopediatrics, Inc. (2)
- Product codes: HRS (15), HSB (7), NKB (5), HTY (4), KTT (3), OSH (3), HWC (2), OWI (2), PGM (1), OLO (1), MDI (1), MBI (1)
- 510(k) review time since 2016: median 112 days, against 91 for FDA's reviews in the same codes and years (11 of 26 faster)
- Predicates its devices cite: 144 (47 its own); citations of its devices by later devices: 72 (47 its own)
- Recalls linked to its devices: 46 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 31 (https://510kreport.com/company/synthes-usa)
- Smith & Nephew, Inc.: 14 (https://510kreport.com/company/smith-nephew)
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Biomet, Inc.: 4 (https://510kreport.com/company/biomet)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Depuyacromed: 4 (https://510kreport.com/company/depuyacromed)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Pega Medical, Inc.: 2 (https://510kreport.com/company/pega-medical)

## Firms that cite its devices most
- Orthofix, Inc.: 4 (https://510kreport.com/company/orthofix)
- Pega Medical, Inc.: 3 (https://510kreport.com/company/pega-medical)
- Wishbone Medical, Inc.: 2 (https://510kreport.com/company/wishbone-medical)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Response Ortho Solutions, LLC: 2 (https://510kreport.com/company/response-ortho-solutions)
- Maxxion Medical, LLC / Baumer SA: 1 (https://510kreport.com/company/maxxion-medical-baumer)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)

## Its most-cited devices
- K083286: Orthopediatrics Pediloc Locking Plate System (2009), cited by 9
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System (2011), cited by 4
- K100240: Orthopediatrics Pediloc Tibia Plate System (2010), cited by 4
- K172583: OrthoPediatrics PediNail Intramedullary Platform (2018), cited by 4
- K120291: OP Spine System (2012), cited by 4
- K073344: Orthopediatrics Plating System (2008), cited by 3

## Recent decisions
- K261345: Pediatric Nailing Platform  Femur (Sep 24, 2026)
- K260323: OrthoPediatrics® Locking Cannulated Blade Plate System (Apr 30, 2026)
- K252600: Pediatric Plating Platform I Small-Mini (Oct 9, 2025)
- K251362: PediFlex™ Flexible Nail System (Jun 24, 2025)
- K243963: Pediatric Plating Platform  Hip (Apr 29, 2025)
- K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur (Apr 1, 2025)
- K241816: VerteGlide Spinal Growth Guidance System (Mar 14, 2025)
- K243798: Orthex External Fixation System (Mar 7, 2025)

Source page: https://510kreport.com/company/orthopediatrics