Ortho Development Corp.: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “Ortho Development Corp.” (first 1996, latest 2025), across 20 product codes in 2 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 98 days, against 98 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 | 0 | — |
| 2013 | 5 | 155 |
| 2014 | 5 | 126 |
| 2015 | 1 | 84 |
| 2016 | 2 | 67 |
| 2017 | 2 | 136 |
| 2018 | 4 | 105 |
| 2019 | 0 | — |
| 2020 | 1 | 56 |
| 2021 | 3 | 253 |
| 2022 | 0 | — |
| 2023 | 1 | 29 |
| 2024 | 3 | 29 |
| 2025 | 2 | 66 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ortho Development Corp. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 15 | 15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 13 | 13 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 6 | 6 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 5 | 5 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
Plus 10 more product codes.
Review panels
Most recent Ortho Development Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral Components | MBH | 2025-12-19 | 84 |
| K251052 | Trivicta® Hip Stem | MEH | 2025-05-22 | 49 |
| K242984 | BKS Revision System | JWH | 2024-10-25 | 29 |
| K242833 | Legend® Acetabular Shell | LPH | 2024-10-11 | 22 |
| K233758 | Trivicta Hip Stem | MEH | 2024-03-08 | 105 |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | JWH | 2023-10-25 | 29 |
| K211086 | The Progen Trochanteric Nail System | HSB | 2021-12-21 | 253 |
| K211471 | Balanced Knee System Uni | HSX | 2021-12-16 | 219 |
| K203023 | Pisces Spinal System | NKB | 2021-07-14 | 285 |
| K200281 | The Gecko Spinal System | OWI | 2020-03-31 | 56 |
54 earlier clearances. See the full list in Caduvo.
Recalls
28 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2019-05-30.
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.
Device clinical trials
An industry sponsor named Ortho Development Corp. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04277416: Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty (Enrolling by invitation, started 2020-02-28)
- NCT02362867: Balanced Knee System Clinical Protocol for IRB Approval (Completed, started 2003-01)
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.
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Clinical Diagnostics (16 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Pared Instruments, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho Development Corp.?
FDA lists 64 510(k) clearances under the applicant name “Ortho Development Corp.” (first 1996, latest 2025), across 20 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ortho Development Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Development Corp. is 94 days. Since 2017: 98 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ortho Development Corp.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 15); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 13); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 6).
Next steps
- See all 64 Ortho Development Corp. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Ortho Development 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.