K2m, Inc.: FDA filings under this applicant name
FDA lists 119 510(k) clearances under 3 spellings of the applicant name “K2m, Inc.” (first 2007, latest 2026), across 18 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 92 days, against 91 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 | 11 | 72 |
| 2013 | 9 | 77 |
| 2014 | 11 | 104 |
| 2015 | 14 | 92 |
| 2016 | 10 | 75 |
| 2017 | 10 | 92 |
| 2018 | 11 | 94 |
| 2019 | 3 | 70 |
| 2020 | 4 | 88 |
| 2021 | 0 | — |
| 2022 | 1 | 300 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 3 | 88 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name K2m, Inc. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 19 | 19 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 18 | 18 |
| MNI | Orthosis, Spinal Pedicle Fixation | 14 | 14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 13 | 13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 10 | 10 |
| OLO | Orthopedic Stereotaxic Instrument | 7 | 7 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 7 | 7 |
| MQP | Spinal Vertebral Body Replacement Device | 6 | 6 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 6 | 6 |
| NKG | Posterior Cervical Screw System | 5 | 5 |
Plus 8 more product codes.
Review panels
- Orthopedic (118)
- General and Plastic Surgery (1)
Most recent K2m, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260546 | Q Pedicle Instruments | OLO | 2026-03-17 | 27 |
| K253545 | Vulcan Spinal System | NKB | 2026-02-10 | 88 |
| K252873 | Q Interbody Instruments | OLO | 2026-02-06 | 149 |
| K211320 | CAPRI Corpectomy Cage System | PLR | 2022-02-24 | 300 |
| K202528 | Cannulated Power Driver Attachment | NKB | 2020-10-26 | 55 |
| K201006 | K2M Navigation Instruments | OLO | 2020-08-07 | 112 |
| K193203 | MOJAVE Expandable Interbody System | MAX | 2020-02-18 | 90 |
| K193129 | Yukon OCT Spinal System | NKG | 2020-02-07 | 87 |
| K192911 | Brainlab Compatible K2M Navigation Instruments | OLO | 2019-11-14 | 30 |
| K190179 | SAHARA Stabilization System | OVD | 2019-10-03 | 244 |
109 earlier clearances. See the full list in Caduvo.
Recalls
39 product recalls in 12 recall events; 3 initiated in the last five years. Most recent: 2022-06-13.
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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- K2m, Inc. (100)
- K2m (16)
- K2m, Incorporated (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under K2m, Inc.?
FDA lists 119 510(k) clearances under 3 spellings of the applicant name “K2m, Inc.” (first 2007, latest 2026), across 18 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 K2m, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name K2m, Inc. is 88 days. Since 2017: 92 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under K2m, Inc.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 19); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 18); MNI (Orthosis, Spinal Pedicle Fixation, 14).
Next steps
- See all 119 K2m, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, K2m, 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.