OrthoPediatrics Corp.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “OrthoPediatrics Corp.” (first 2008, latest 2026), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 114 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 66 |
| 2013 | 2 | 100 |
| 2014 | 1 | 159 |
| 2015 | 1 | 73 |
| 2016 | 3 | 41 |
| 2017 | 2 | 122 |
| 2018 | 2 | 184 |
| 2019 | 3 | 142 |
| 2020 | 2 | 98 |
| 2021 | 2 | 135 |
| 2022 | 2 | 76 |
| 2023 | 3 | 111 |
| 2024 | 1 | 115 |
| 2025 | 6 | 70 |
| 2026 | 1 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name OrthoPediatrics Corp. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 15 | 15 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| NKB | Thoracolumbosacral Pedicle Screw System | 5 | 5 |
| HTY | Pin, Fixation, Smooth | 4 | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 3 | 3 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| MDI | Prosthesis, Rib Replacement | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (44)
Most recent OrthoPediatrics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | HRS | 2026-04-30 | 90 |
| K252600 | Pediatric Plating Platform I Small-Mini | HRS | 2025-10-09 | 52 |
| K251362 | PediFlex Flexible Nail System | HTY | 2025-06-24 | 54 |
| K243963 | Pediatric Plating Platform Hip | HRS | 2025-04-29 | 127 |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | HSB | 2025-04-01 | 29 |
| K241816 | VerteGlide Spinal Growth Guidance System | PGM | 2025-03-14 | 263 |
| K243798 | Orthex External Fixation System | KTT | 2025-03-07 | 86 |
| K233105 | RESPONSE Rib and Pelvic System | MDI | 2024-01-20 | 115 |
| K231266 | Pediatric Nailing Platform Tibia | HSB | 2023-08-21 | 111 |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | NKB | 2023-03-23 | 248 |
34 earlier clearances. See the full list in Caduvo.
Recalls
52 product recalls in 22 recall events; 2 initiated in the last five years. Most recent: 2022-09-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
ORTHOPEDIATRICS CORP (KIDS): EDGAR filings, CIK 1425450. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Orthopediatrics Canada Ulc Dba Pega Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under OrthoPediatrics Corp.?
FDA lists 44 510(k) clearances under the applicant name “OrthoPediatrics Corp.” (first 2008, latest 2026), across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by OrthoPediatrics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name OrthoPediatrics Corp. is 86 days. Since 2017: 114 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under OrthoPediatrics Corp.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 15); HSB (Rod, Fixation, Intramedullary And Accessories, 6); NKB (Thoracolumbosacral Pedicle Screw System, 5).
Next steps
- See all 44 OrthoPediatrics Corp. clearances with predicates and recalls
- Run predicate analysis for product code HRS, OrthoPediatrics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.