Zimmer Trabecular Metal Technology: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Zimmer Trabecular Metal Technology” (first 2007, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Zimmer Biomet, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 144 |
| 2013 | 1 | 100 |
| 2014 | 1 | 207 |
| 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 3 | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Zimmer Trabecular Metal Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133784 | VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION | ODP | 2014-07-07 | 207 |
| K123602 | TM ARDIS INTERBODY SYSTEM INSERTER | MAX | 2013-03-01 | 100 |
| K120990 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL | MBH | 2012-06-29 | 88 |
| K120203 | TM-400 DEVICE | MAX | 2012-06-15 | 144 |
| K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION | MAX | 2012-05-29 | 180 |
| K111983 | VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX | ODP | 2011-11-18 | 129 |
| K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS | MBH | 2011-02-15 | 77 |
| K103033 | TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX | ODP | 2011-01-10 | 89 |
| K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS | MBH | 2010-12-13 | 74 |
| K093127 | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET | MQP | 2010-03-04 | 153 |
3 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2019-02-01.
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 Biomet Spine, Inc. (15 510(k)s)
- Zimmer Medizinsysteme GmbH (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 Trabecular Metal Technology?
FDA lists 13 510(k) clearances under the applicant name “Zimmer Trabecular Metal Technology” (first 2007, latest 2014), across 5 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 Trabecular Metal Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer Trabecular Metal Technology is 111 days.
Which FDA product codes appear under Zimmer Trabecular Metal Technology?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, 3); MQP (Spinal Vertebral Body Replacement Device, 3).
Next steps
- See all 13 Zimmer Trabecular Metal Technology clearances with predicates and recalls
- Run predicate analysis for product code MAX, Zimmer Trabecular Metal Technology'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.