Synthes Spine: FDA clearances and approvals
Synthes Spine has 54 FDA 510(k) clearances (first 1995, latest 2012), across 12 product codes in 3 review panels. Median 510(k) review time: 90 days. openFDA lists 13 product recalls by a recalling firm named Synthes Spine.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 100 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 13 | 13 |
| NKB | Thoracolumbosacral Pedicle Screw System | 10 | 10 |
| MNI | Orthosis, Spinal Pedicle Fixation | 7 | 7 |
| MQP | Spinal Vertebral Body Replacement Device | 6 | 6 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 5 | 5 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| OMR | Vessel Guard Or Cover | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (51)
- Cardiovascular (2)
- Neurology (1)
Most recent Synthes Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | HAW | 2012-12-17 | 145 |
| K120838 | SYNTHES MATRIX SYSTEM | NKB | 2012-07-31 | 133 |
| K121852 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | OVE | 2012-07-25 | 30 |
| K111048 | SYNTHES SCOUT TACK FIXATION | OMR | 2012-06-14 | 426 |
| K120928 | SYNTHES MATRIX SYSTEM | NKB | 2012-05-18 | 52 |
| K120571 | SYNTHES USS CONNECTOR | NKB | 2012-05-14 | 77 |
| K113149 | SYNTHES USS CONNECTORS | MNI | 2012-02-01 | 100 |
| K113044 | SYNTHES MIRS | NKB | 2011-12-21 | 70 |
| K112459 | SYNTHES ZERO-P | OVE | 2011-12-12 | 108 |
| K111358 | SYNTHES USS | NKB | 2011-11-18 | 186 |
44 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2009-04-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Synthes Spine have?
Synthes Spine has 54 FDA 510(k) clearances (first 1995, latest 2012), across 12 product codes in 3 review panels.
How long does FDA take to clear Synthes Spine's 510(k)s?
The median time from FDA receipt to decision across Synthes Spine's cleared 510(k)s is 90 days.
What devices does Synthes Spine make?
Its most frequent FDA product codes are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 13); NKB (Thoracolumbosacral Pedicle Screw System, 10); MNI (Orthosis, Spinal Pedicle Fixation, 7).
Has Synthes Spine had device recalls?
openFDA lists 13 product recalls in 6 recall events by a recalling firm whose name matches Synthes Spine; the most recent began 2009-04-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 54 Synthes Spine clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Synthes Spine's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.