Link America, Inc.: FDA clearances and approvals
Link America, Inc. has 21 FDA 510(k) clearances (first 1984, latest 1997), across 12 product codes in 2 review panels. Median 510(k) review time: 90 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 2 | 2 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HTD | Forceps | 1 | 1 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Link America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | JDJ | 1997-10-22 | 90 |
| K964458 | ELLIS EXTERNAL MINI-FIXATOR SYSTEM | KTT | 1996-12-09 | 32 |
| K955296 | LINK MP RECONSTRUCTION HIP | JDI | 1996-02-14 | 90 |
| K954186 | SLED UNICOMPARTMENT KNEE SYSTEM | HSX | 1996-01-26 | 142 |
| K931571 | LINK CERAMIC HEADS 12/14 X 32MM | LZO | 1994-04-19 | 385 |
| K931572 | LINK CERAMIC HEADS 14/16 X 32MM | LZO | 1994-03-28 | 363 |
| K920756 | FELDMUHLE CERAMIC HEAD | LZO | 1992-05-18 | 89 |
| K914804 | RADIUS OSTEOTOMY PLATES | HRS | 1992-04-29 | 188 |
| K914803 | SCHWABE RADIUS PLATES | HRS | 1992-04-28 | 187 |
| K895507 | LINK GIEBEL BLADE PLATE SYSTEM | KTT | 1990-03-13 | 183 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Link America, Inc..
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.
Device clinical trials
Link America, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00586781: Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease (Completed, started 2001-09)
Frequently asked questions
How many FDA 510(k) clearances does Link America, Inc. have?
Link America, Inc. has 21 FDA 510(k) clearances (first 1984, latest 1997), across 12 product codes in 2 review panels.
How long does FDA take to clear Link America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Link America, Inc.'s cleared 510(k)s is 90 days.
What devices does Link America, Inc. make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 3); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 3); HWC (Screw, Fixation, Bone, 2).
Has Link America, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Link America, Inc. Related entities may recall under other names.
Next steps
- See all 21 Link America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Link America, Inc.'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.