Biomet Spine: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Biomet Spine” (first 2007, latest 2016), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 1 | 63 |
| 2013 | 0 | — |
| 2014 | 2 | 92 |
| 2015 | 5 | 114 |
| 2016 | 2 | 164 |
| 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| NKB | Thoracolumbosacral Pedicle Screw System | 5 | 5 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| NVR | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | 1 | 1 |
Review panels
- Orthopedic (23)
Most recent Biomet Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152622 | Alta ACDF System | OVE | 2016-07-08 | 298 |
| K153695 | Biomet Spine Fusion System | MAX | 2016-01-21 | 29 |
| K151974 | Polaris Spinal System | NKB | 2015-11-13 | 120 |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System | OVE | 2015-08-12 | 114 |
| K151483 | Biomet Spine Fusion System | MAX | 2015-07-31 | 59 |
| K151224 | Lineum OCT Spine System | NKG | 2015-06-30 | 54 |
| K142634 | Biomet Spine Fusion System | MAX | 2015-03-12 | 176 |
| K141791 | BIOMET FUSION SYSTEM | OVD | 2014-10-09 | 99 |
| K141804 | POLARIS SPINAL SYSTEM - HA COATED | NKB | 2014-09-25 | 84 |
| K121130 | POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS | NKB | 2012-06-15 | 63 |
13 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2016-02-12.
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.
- Biomet, Inc. (445 510(k)s)
- Biomet Manufacturing Corp (128 510(k)s)
- Biomet Orthopedics, Inc. (41 510(k)s)
- Biomet 3i, Inc. (32 510(k)s)
- Biomet Microfixation (30 510(k)s)
- Biomet Spine (Aka Ebi, LLC) (13 510(k)s)
- Biomet Sports Medicine (13 510(k)s)
- Biomet Trauma (7 510(k)s)
- Biomet Micofixation (3 510(k)s)
- Biomet Trauma (Aka Ebi, Lp) (3 510(k)s)
- Biomet UK, Ltd. (3 510(k)s)
- Biomet Manufactuting Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomet Spine?
FDA lists 23 510(k) clearances under the applicant name “Biomet Spine” (first 2007, latest 2016), across 10 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 Biomet Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomet Spine is 90 days.
Which FDA product codes appear under Biomet Spine?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5); NKB (Thoracolumbosacral Pedicle Screw System, 5); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 4).
Next steps
- See all 23 Biomet Spine clearances with predicates and recalls
- Run predicate analysis for product code MAX, Biomet Spine'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.