Ortho Kinematics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ortho Kinematics, Inc.” (first 2011, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 33 days, against 127 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 | 1 | 140 |
| 2014 | 1 | 28 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 3 | 33 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ortho Kinematics, Inc. took a median 33 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
Review panels
- Radiology (6)
Most recent Ortho Kinematics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173247 | Surgical Planning Software version 1.1 | LLZ | 2017-11-08 | 33 |
| K172327 | VMA System version 3.0 | LLZ | 2017-08-25 | 24 |
| K171617 | OKI Surgical Planning Software | LLZ | 2017-08-22 | 82 |
| K133875 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA | LLZ | 2014-01-17 | 28 |
| K130743 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL | LLZ | 2013-08-06 | 140 |
| K112109 | THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE | LLZ | 2011-12-22 | 153 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-05-23.
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.
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 Development Corp. (64 510(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 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 Kinematics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Ortho Kinematics, Inc.” (first 2011, latest 2017), across 1 product code 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 Ortho Kinematics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Kinematics, Inc. is 58 days. Since 2017: 33 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ortho Kinematics, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6).
Next steps
- See all 6 Ortho Kinematics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Ortho Kinematics, Inc.'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.