Biomet Sports Medicine: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Biomet Sports Medicine” (first 2007, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 107 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 | 0 | — |
| 2013 | 2 | 280 |
| 2014 | 1 | 176 |
| 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 8 | 8 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
Review panels
- Orthopedic (12)
- Dental (1)
Most recent Biomet Sports Medicine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140908 | JUGGERKNOT MINI SOFT ANCHOR | DZL | 2014-10-02 | 176 |
| K122437 | NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS | MBI | 2013-10-18 | 434 |
| K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF | MBI | 2013-03-18 | 125 |
| K110879 | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR | MBI | 2011-08-19 | 142 |
| K111564 | MAXFIRE MARXMEN MENISCAL REPAIR DEVICE | MBI | 2011-06-16 | 10 |
| K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM | JDQ | 2011-05-03 | 117 |
| K103145 | HAMMERLOC TM TIBIAL FIXATION DEVICE | MBI | 2011-02-09 | 107 |
| K101063 | SLEEVE WITH ZIPLOOP FIXATION DEVICES | MBI | 2010-06-23 | 68 |
| K083070 | TOGGLELOC SYSTEM | MBI | 2008-12-16 | 62 |
| K071816 | HARPOON SUTURE ANCHOR | HWC | 2007-09-20 | 80 |
3 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2008-04-24.
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 (23 510(k)s)
- Biomet Spine (Aka Ebi, LLC) (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 Sports Medicine?
FDA lists 13 510(k) clearances under the applicant name “Biomet Sports Medicine” (first 2007, latest 2014), across 4 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 Biomet Sports Medicine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomet Sports Medicine is 107 days.
Which FDA product codes appear under Biomet Sports Medicine?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 8); HWC (Screw, Fixation, Bone, 3); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 13 Biomet Sports Medicine clearances with predicates and recalls
- Run predicate analysis for product code MBI, Biomet Sports Medicine'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.