FDA product code KWH: Prosthesis, Toe, Constrained, Polymer
KWH is the FDA product code for prosthesis, toe, constrained, polymer. It is a Class II device, regulated under 21 CFR 888.3720 and reviewed by the Orthopedic panel. FDA has cleared 21 510(k) submissions under KWH, from 14 different applicants. The average 510(k) review took 116 days (median 88). FDA has posted 2 recalls for KWH devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Toe, Constrained, Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3720 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 102 |
| 2019 | 1 | 265 |
| 2020 | 1 | 205 |
Compare with all 510(k) review times · Search every KWH clearance
Top KWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nexa Orthopedics, Inc. | 4 | 2003-01-17 |
| In2bones USA, LLC | 2 | 2018-02-23 |
| Osteomed Corp. | 2 | 2002-11-26 |
| Sgarlato Laboratories, Inc. | 2 | 1991-05-29 |
| Dow Corning Corp. Healthcare Industries Materials | 2 | 1980-06-09 |
9 more applicants have KWH clearances. See the full list in Caduvo.
Most recent KWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191966 | Brm Extremities | NewPrim System | 2020-02-13 | 205 |
| K190136 | Fusion Orthopedics, LLC | Fusion Silastic System | 2019-10-21 | 265 |
| K173491 | In2bones USA, LLC | RTS Lesser MTP Implant System | 2018-02-23 | 102 |
| K153609 | In2bones USA, LLC | RTS Flexible 1 MPJ Implant w/Grommets | 2016-09-08 | 266 |
| K102601 | Ortho-Pro, LLC | ORTHOFLEX ROD | 2011-01-14 | 127 |
Recalls for KWH devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-04-06.
Frequently asked questions
What is FDA product code KWH?
KWH is the FDA product code for prosthesis, toe, constrained, polymer. It is a Class II device, regulated under 21 CFR 888.3720 and reviewed by the Orthopedic panel.
What device class is KWH?
Class II, regulation 21 CFR 888.3720. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWH?
Across 21 cleared submissions the average was 116 days from receipt to decision (median 88).
Which companies have the most KWH clearances?
Nexa Orthopedics, Inc. (4); In2bones USA, LLC (2); Osteomed Corp. (2); Sgarlato Laboratories, Inc. (2); Dow Corning Corp. Healthcare Industries Materials (2).
Have KWH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code KWH
- Run a recall and safety report across every KWH manufacturer
- Watch product code KWH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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