Zimmer Spine, Inc.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Zimmer Spine, Inc.” (first 2004, latest 2016), plus 1 PMA decision, across 13 product codes in 2 review panels. Median 510(k) review time under this name: 88 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 | 2 | 67 |
| 2013 | 9 | 73 |
| 2014 | 7 | 105 |
| 2015 | 5 | 88 |
| 2016 | 1 | 60 |
| 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 13 | 13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 | 7 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 7 | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| NKG | Posterior Cervical Screw System | 2 | 2 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 2 |
| FST | Light, Surgical, Fiberoptic | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Zimmer Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation System | NKG | 2016-02-16 | 60 |
| K150896 | Vitality Spinal Fixation System | NKB | 2015-08-31 | 151 |
| K151031 | Virage OCT Spinal Fixation System | NKG | 2015-06-24 | 68 |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System | NKB | 2015-06-18 | 267 |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System | KWQ | 2015-03-20 | 88 |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) | MAX | 2015-02-12 | 87 |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | OWI | 2014-10-29 | 92 |
| K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM | KWQ | 2014-09-23 | 109 |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | KWP | 2014-06-02 | 195 |
| K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | KWQ | 2014-05-21 | 72 |
33 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P950002 | PMA | BAK INTERBODY FUSION SYSTEM | 1996-09-20 |
Recalls
6 product recalls in 5 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.
- Zimmer, Inc. (422 510(k)s)
- Zimmer Dental, Inc. (40 510(k)s)
- Zimmer Biomet Spine, Inc. (15 510(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 Spine, Inc.?
FDA lists 43 510(k) clearances under the applicant name “Zimmer Spine, Inc.” (first 2004, latest 2016), plus 1 PMA decision, across 13 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 Zimmer Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer Spine, Inc. is 88 days.
Which FDA product codes appear under Zimmer Spine, Inc.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 13); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 7); NQP (Posterior Metal/Polymer Spinal System, Fusion, 7).
Next steps
- See all 43 Zimmer Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Zimmer 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.