FDA product code KWP: Appliance, Fixation, Spinal Interlaminal
KWP is the FDA product code for appliance, fixation, spinal interlaminal. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel. FDA has cleared 430 510(k) submissions under KWP, from 142 different applicants. The average 510(k) review took 130 days (median 88). FDA has posted 68 recalls for KWP devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class II |
| Regulation | 21 CFR 888.3050 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KWP clearance
Top KWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Sofamor Danek | 25 | 2009-04-17 |
| Medtronic Sofamor Danek, Inc. | 19 | 2012-06-29 |
| Synthes (Usa) | 17 | 2009-07-10 |
| Danek Medical, Inc. | 16 | 1994-05-04 |
| Acromed Corp. | 14 | 1996-11-27 |
137 more applicants have KWP clearances. See the full list in Caduvo.
Most recent KWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143278 | L&K BIOMED Co., Ltd. | LnK Posterior Cervical Fixation System | 2015-07-29 | 257 |
| K150753 | Stryker Corporation | OASYS System | 2015-06-09 | 78 |
| K150851 | Precision Spine, Inc. | Sure Lok Mini Posterior Cervical/Upper Thoracic System | 2015-06-04 | 65 |
| K142867 | Reliance Medical Systems, LLC | Reliance Posterior Cervical-Thoracic System | 2015-04-29 | 210 |
| K150254 | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Streamline OCT Occipito-Cervico-Thoracic System | 2015-04-28 | 84 |
Recalls for KWP devices
68 product recalls in 39 recall events; 8 initiated in the last five years and 10 still open. Most recent: 2023-02-16.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 3 |
| 2022 | 3 |
| 2023 | 5 |
Frequently asked questions
What is FDA product code KWP?
KWP is the FDA product code for appliance, fixation, spinal interlaminal. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel.
What device class is KWP?
Class II, regulation 21 CFR 888.3050. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWP?
Across 430 cleared submissions the average was 130 days from receipt to decision (median 88).
Which companies have the most KWP clearances?
Medtronic Sofamor Danek (25); Medtronic Sofamor Danek, Inc. (19); Synthes (Usa) (17); Danek Medical, Inc. (16); Acromed Corp. (14).
Have KWP devices been recalled?
Yes: 68 product recalls across 39 recall events; the most recent began 2023-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KWP
- Run a recall and safety report across every KWP manufacturer
- Watch product code KWP 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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