Kinetikos Medical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Kinetikos Medical, Inc.” (first 1994, latest 2006), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 | 0 | — |
| 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 7 | 7 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 3 | 3 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HXB | Probe | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 | 1 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 | 1 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 1 | 1 |
Review panels
- Orthopedic (19)
Most recent Kinetikos Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061749 | ECLIPSE TOTAL ANKLE IMPLANT | HSN | 2006-11-22 | 154 |
| K061465 | KMI CEMENT RESTRICTOR IMPLANT | JDK | 2006-10-05 | 132 |
| K051611 | MBARESORB IMPLANT | HWC | 2005-09-06 | 81 |
| K041461 | KMI DISTAL VOLAR RADIUS PLATE SYSTEM | HRS | 2004-08-16 | 75 |
| K032806 | KATALYST RADIAL HEAD IMPLANT | KWI | 2004-04-16 | 220 |
| K040356 | KOMPRESSOR SCREW SYSTEM | HWC | 2004-03-01 | 17 |
| K024233 | KOMPRESSOR SCREW SYSTEM | HWC | 2003-02-06 | 45 |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | JWJ | 2003-02-05 | 30 |
| K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | KWD | 2002-12-12 | 30 |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | JWJ | 2002-05-03 | 72 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kinetikos Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kinetikos Medical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Kinetikos Medical, Inc.” (first 1994, latest 2006), across 9 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 Kinetikos Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kinetikos Medical, Inc. is 76 days.
Which FDA product codes appear under Kinetikos Medical, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 7); HRS (Plate, Fixation, Bone, 3); JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained, 3).
Next steps
- See all 19 Kinetikos Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Kinetikos Medical, 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.