Orthosoft, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Orthosoft, Inc.” (first 1998, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 50 days. 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 | 121 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 12 | 12 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Neurology (12)
- Orthopedic (2)
Most recent Orthosoft, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131409 | CAS PSI KNEE SYSTEM | JWH | 2013-09-13 | 121 |
| K100599 | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM | OLO | 2010-04-05 | 33 |
| K071929 | NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL | HAW | 2007-09-19 | 68 |
| K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 | HAW | 2007-07-20 | 28 |
| K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 | HAW | 2006-04-28 | 77 |
| K043536 | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE | HAW | 2005-01-14 | 23 |
| K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | HAW | 2004-06-22 | 29 |
| K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE | HAW | 2003-10-21 | 29 |
| K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 | HAW | 2003-05-23 | 70 |
| K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 | HAW | 2003-05-09 | 28 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthosoft, Inc..
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.
- Orthosoft Inc (D/B/A Zimmer Cas) (20 510(k)s)
- Orthosoft D/B/A Zimmer Cas (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthosoft, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Orthosoft, Inc.” (first 1998, latest 2013), across 3 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 Orthosoft, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthosoft, Inc. is 50 days.
Which FDA product codes appear under Orthosoft, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 12); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 1); OLO (Orthopedic Stereotaxic Instrument, 1).
Next steps
- See all 14 Orthosoft, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Orthosoft, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.