Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nexa Orthopedics, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
89 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072710 | NEXFIX COMPRESSION PIN | Nexa Orthopedics, Inc. | 2007-11-08 | 44 | 0 |
| K071147 | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM | Nexa Orthopedics, Inc. | 2007-07-20 | 87 | 0 |
| K070688 | NEXFIX COMPRESSION STAPLE | Nexa Orthopedics, Inc. | 2007-05-18 | 67 | 0 |
| K060386 | NEXA CARPO METACARPAL IMPLANT | Nexa Orthopedics, Inc. | 2006-05-10 | 85 | 0 |
| K060071 | NEXA COMPRESSION SCREW | Nexa Orthopedics, Inc. | 2006-01-26 | 17 | 0 |
| K053408 | NEXA BONE PLATE AND SCREW SYSTEM | Nexa Orthopedics, Inc. | 2005-12-22 | 15 | 0 |
| K053394 | NEXA BONE SCREW SYSTEM | Nexa Orthopedics, Inc. | 2005-12-14 | 8 | 0 |
| K051740 | TAPERED COMPRESSION PIN | Nexa Orthopedics, Inc. | 2005-09-06 | 70 | 0 |
| K051406 | OSTEOCURE RESORBABLE BEAD KIT | Nexa Orthopedics, Inc. | 2005-08-01 | 62 | 0 |
| K033046 | SUBTALAR PEG IMPLANT | Nexa Orthopedics, Inc. | 2003-12-23 | 85 | 0 |
| K032902 | SUBTALAR ARTHRORISIS IMPLANT | Nexa Orthopedics, Inc. | 2003-12-15 | 89 | 0 |
| K023531 | LESSER METATARSAL PHALANGEAL JOINT IMPLANT | Nexa Orthopedics, Inc. | 2003-01-17 | 88 | 1 |
| K023562 | MODIFICATION TO CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-11-13 | 21 | 0 |
| K023086 | CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-10-04 | 17 | 0 |
| K981194 | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 1998-06-30 | 89 | 0 |
| K971047 | FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT | Nexa Orthopedics, Inc. | 1997-06-20 | 91 | 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