Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Link America, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
195 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | Link America, Inc. | 1997-10-22 | 90 | 0 |
| K964458 | ELLIS EXTERNAL MINI-FIXATOR SYSTEM | Link America, Inc. | 1996-12-09 | 32 | 0 |
| K955296 | LINK MP RECONSTRUCTION HIP | Link America, Inc. | 1996-02-14 | 90 | 21 |
| K954186 | SLED UNICOMPARTMENT KNEE SYSTEM | Link America, Inc. | 1996-01-26 | 142 | 32 |
| K931571 | LINK CERAMIC HEADS 12/14 X 32MM | Link America, Inc. | 1994-04-19 | 385 | 0 |
| K931572 | LINK CERAMIC HEADS 14/16 X 32MM | Link America, Inc. | 1994-03-28 | 363 | 0 |
| K920756 | FELDMUHLE CERAMIC HEAD | Link America, Inc. | 1992-05-18 | 89 | 0 |
| K914804 | RADIUS OSTEOTOMY PLATES | Link America, Inc. | 1992-04-29 | 188 | 0 |
| K914803 | SCHWABE RADIUS PLATES | Link America, Inc. | 1992-04-28 | 187 | 0 |
| K895507 | LINK GIEBEL BLADE PLATE SYSTEM | Link America, Inc. | 1990-03-13 | 183 | 0 |
| K873507 | LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM | Link America, Inc. | 1987-09-16 | 16 | 0 |
| K871535 | SMILJANIC BONE REPOSITIONING FORCEPS | Link America, Inc. | 1987-05-14 | 24 | 0 |
| K854935 | LINK METAL-BACKED ACETABULAR CUPS | Link America, Inc. | 1986-03-05 | 85 | 0 |
| K854465 | LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM | Link America, Inc. | 1986-02-10 | 96 | 0 |
| K854825 | LINK SMALL BONE PLATES | Link America, Inc. | 1986-01-21 | 49 | 0 |
| K853704 | LINK DYNAMIC STAPLE | Link America, Inc. | 1986-01-21 | 139 | 0 |
| K854827 | LINK CORTICAL SCREWS | Link America, Inc. | 1985-12-27 | 24 | 0 |
| K854826 | LINK CANCELLOUS SCREWS | Link America, Inc. | 1985-12-27 | 24 | 0 |
| K852365 | LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM | Link America, Inc. | 1985-12-16 | 195 | 0 |
| K852369 | LIDGRER-LUND ACETABULAR SOCKETS | Link America, Inc. | 1985-06-18 | 14 | 0 |
| K840423 | HARRINGTON-TYPE INSTRU-SCOLIOSIS | Link America, Inc. | 1984-03-23 | 52 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda