Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Turnkey Intergration USA, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
323 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991405 | OMNI-FIX, HUMERAL NAIL | Turnkey Intergration USA, Inc. | 1999-06-29 | 68 | 0 |
| K990523 | B2C, ESPACE REVISION CUP SYSTEM | Turnkey Intergration USA, Inc. | 1999-04-30 | 70 | 0 |
| K990307 | OMNI-FIX, NAIL SYSTEM | Turnkey Intergration USA, Inc. | 1999-04-01 | 59 | 0 |
| K972411 | LINK CEMENT PLUG | Turnkey Intergration USA, Inc. | 1997-08-29 | 64 | 0 |
| K970284 | ARTOS, DIPLOS SYSTEM | Turnkey Intergration USA, Inc. | 1997-04-21 | 87 | 0 |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Turnkey Intergration USA, Inc. | 1997-03-13 | 63 | 0 |
| K953653 | LUBINUS SP II HIP SYSTEM | Turnkey Intergration USA, Inc. | 1995-11-06 | 95 | 5 |
| K943986 | LINK ENDO MODEL REVISION CUP | Turnkey Intergration USA, Inc. | 1995-07-05 | 323 | 0 |
| K951355 | LINK SADDLE PROTHESIS | Turnkey Intergration USA, Inc. | 1995-05-25 | 78 | 0 |
| K950397 | SYSTEM 22 VALVE | Turnkey Intergration USA, Inc. | 1995-04-14 | 72 | 0 |
| K940297 | UNIVERSAL WRIST | Turnkey Intergration USA, Inc. | 1995-02-06 | 381 | 0 |
| K943277 | LINK SADDLE PROTHESIS | Turnkey Intergration USA, Inc. | 1995-01-26 | 203 | 0 |
| K931960 | NUFFIELD TOTAL KNEE | Turnkey Intergration USA, Inc. | 1994-10-07 | 534 | 0 |
| K923911 | INTRINSIC STEM | Turnkey Intergration USA, Inc. | 1993-04-14 | 253 | 0 |
| K923898 | C-FIT CEMENTED HIP STEM | Turnkey Intergration USA, Inc. | 1992-11-04 | 92 | 0 |
| K913708 | VENUS HIP | Turnkey Intergration USA, Inc. | 1992-01-27 | 164 | 0 |
| K912985 | LIMA 28MM CERAMIC HEAD, MODIFICATION | Turnkey Intergration USA, Inc. | 1991-12-24 | 175 | 0 |
| K913282 | LIMA RPS SHOULDER | Turnkey Intergration USA, Inc. | 1991-10-21 | 89 | 0 |
| K912936 | MAY HUMERUS PLATES | Turnkey Intergration USA, Inc. | 1991-09-06 | 63 | 0 |
| K911338 | LIMA CEMENT RESTRICTOR | Turnkey Intergration USA, Inc. | 1991-06-28 | 94 | 0 |
| K910547 | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) | Turnkey Intergration USA, Inc. | 1991-04-12 | 64 | 0 |
| K910548 | FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) | Turnkey Intergration USA, Inc. | 1991-04-09 | 61 | 0 |
| K910010 | Q SYSTEM 28 HIP STEM | Turnkey Intergration USA, Inc. | 1991-03-12 | 69 | 0 |
| K903957 | VSP HIP STEM | Turnkey Intergration USA, Inc. | 1990-11-26 | 90 | 0 |
| K902110 | MODIFIED FREEMAN ACETABULAR CUP | Turnkey Intergration USA, Inc. | 1990-08-22 | 105 | 0 |
| K902111 | MODIFIED FREEMAN REVISION ACETABULAR CUP | Turnkey Intergration USA, Inc. | 1990-08-22 | 105 | 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