Zimmer Biomet Spine, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Zimmer Biomet Spine, Inc.” (first 2017, latest 2021), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 74 days, against 90 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 |
|---|---|---|
| 2017 | 3 | 61 |
| 2018 | 2 | 157 |
| 2019 | 5 | 158 |
| 2020 | 1 | 55 |
| 2021 | 4 | 60 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zimmer Biomet Spine, Inc. took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 5 | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| PGM | Growing Rod System | 1 | 1 |
Review panels
- Orthopedic (15)
Most recent Zimmer Biomet Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212023 | Virage Navigation System | OLO | 2021-08-27 | 59 |
| K203218 | CaP Spheres Pellet Pack | MQV | 2021-05-04 | 183 |
| K210275 | Polaris Spinal System | NKB | 2021-04-02 | 60 |
| K203507 | Vitality® Spinal Fixation System | NKB | 2021-01-28 | 59 |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System | KWQ | 2020-10-08 | 55 |
| K191722 | Vital Navigation System | OLO | 2019-12-02 | 158 |
| K192133 | Zimmer Biomet Universal Navigation System | OLO | 2019-10-29 | 83 |
| K190556 | Zimmer Biomet Universal Navigation System | OLO | 2019-10-24 | 233 |
| K183550 | Vitality® Spinal Fixation System | NKB | 2019-04-08 | 109 |
| K181096 | Avenue P Cage System | OVD | 2019-01-15 | 264 |
5 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2023-10-16.
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.
- Zimmer, Inc. (422 510(k)s)
- Zimmer Spine, Inc. (43 510(k)s)
- Zimmer Dental, Inc. (40 510(k)s)
- Zimmer Medizinsysteme GmbH (13 510(k)s)
- Zimmer Trabecular Metal Technology (13 510(k)s)
- Zimmer Elektromedizin GmbH (12 510(k)s)
- Zimmer Trabecular (10 510(k)s)
- Zimmer Biomet (5 510(k)s)
- Zimmer Switzerland Manufacturing GmbH (4 510(k)s)
- Zimmer Cas (3 510(k)s)
- Zimmer Patient Care Division (3 510(k)s)
- Zimmer Austin, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zimmer Biomet Spine, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Zimmer Biomet Spine, Inc.” (first 2017, latest 2021), across 7 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 Zimmer Biomet Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer Biomet Spine, Inc. is 74 days. Since 2017: 74 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zimmer Biomet Spine, Inc.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 5); OLO (Orthopedic Stereotaxic Instrument, 4); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 2).
Next steps
- See all 15 Zimmer Biomet Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Zimmer Biomet Spine, 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.