Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OrthoPediatrics Corp. — Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
211 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 | 90 | 0 |
| K252600 | Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. | 2025-10-09 | 52 | 0 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 | 54 | 0 |
| K243963 | Pediatric Plating Platform Hip | OrthoPediatrics Corp. | 2025-04-29 | 127 | 0 |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform | OrthoPediatrics Corp. | 2025-04-01 | 29 | 0 |
| K241816 | VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. | 2025-03-14 | 263 | 0 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 | 86 | 0 |
| K233105 | RESPONSE™ Rib and Pelvic System | OrthoPediatrics Corp. | 2024-01-20 | 115 | 0 |
| K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023-08-21 | 111 | 0 |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | OrthoPediatrics Corp. | 2023-03-23 | 248 | 0 |
| K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023-02-10 | 53 | 0 |
| K220679 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2022-07-20 | 134 | 0 |
| K220809 | Drive Rail System | OrthoPediatrics Corp. | 2022-04-08 | 18 | 0 |
| K203573 | RESPONSE Navigation Instruments | OrthoPediatrics Corp. | 2021-02-04 | 59 | 0 |
| K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | 2021-01-29 | 211 | 0 |
| K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESP | OrthoPediatrics Corp. | 2020-03-24 | 137 | 0 |
| K200097 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2020-03-16 | 60 | 0 |
| K190321 | Pediatric Nailing PlatformFemur | OrthoPediatrics Corp. | 2019-10-09 | 238 | 0 |
| K190992 | OrthoPediatrics PediFoot Deformity Corrections System | OrthoPediatrics Corp. | 2019-08-06 | 113 | 0 |
| K190324 | OrthoPediatrics Cannulated Screw System | OrthoPediatrics Corp. | 2019-07-05 | 142 | 0 |
| K181390 | Response Spine System, Response 5.5/6.0 Spine System, Respon | OrthoPediatrics Corp. | 2018-09-18 | 112 | 0 |
| K171173 | OrthoPediatrics Titanium PediPlates® System | OrthoPediatrics Corp. | 2017-08-24 | 125 | 0 |
| K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screw | OrthoPediatrics Corp. | 2016-09-27 | 41 | 0 |
| K161267 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2016-08-11 | 98 | 0 |
| K160466 | Response 5.5 Spine System | OrthoPediatrics Corp. | 2016-03-23 | 33 | 0 |
| K150600 | Response 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2015-05-22 | 73 | 0 |
| K140431 | PEDILOC FRAGMENT SYSTEM | OrthoPediatrics Corp. | 2014-07-29 | 159 | 0 |
| K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM | OrthoPediatrics Corp. | 2013-06-20 | 142 | 2 |
| K130655 | RESPONSE SPINE SYSTEM | OrthoPediatrics Corp. | 2013-05-08 | 57 | 0 |
| K121250 | OP SPINE SYSTEM | OrthoPediatrics Corp. | 2012-06-19 | 55 | 0 |
| K120291 | OP SPINE SYSTEM | OrthoPediatrics Corp. | 2012-04-16 | 76 | 0 |
| K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM | OrthoPediatrics Corp. | 2011-08-05 | 122 | 3 |
| K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM | OrthoPediatrics Corp. | 2011-06-17 | 59 | 1 |
| K100240 | ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM | OrthoPediatrics Corp. | 2010-05-17 | 110 | 0 |
| K090666 | PEDIPLATES | OrthoPediatrics Corp. | 2009-04-24 | 42 | 0 |
| K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM | OrthoPediatrics Corp. | 2009-03-11 | 86 | 27 |
| K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM | OrthoPediatrics Corp. | 2009-01-30 | 86 | 5 |
| K082949 | ORTHOPEDIATRICS BONE SCREWS | OrthoPediatrics Corp. | 2008-11-25 | 54 | 0 |
| K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | OrthoPediatrics Corp. | 2008-10-17 | 60 | 0 |
| K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM | OrthoPediatrics Corp. | 2008-07-22 | 64 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda