Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ascension Orthopedics, Inc. · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
196 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 2024-05-30 | 196 | 0 |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | 2023-12-14 | 29 | 0 |
| K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM | Ascension Orthopedics, Inc. | 2013-02-13 | 237 | 0 |
| K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM | Ascension Orthopedics, Inc. | 2011-12-06 | 267 | 0 |
| K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | Ascension Orthopedics, Inc. | 2010-12-21 | 105 | 0 |
| K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM | Ascension Orthopedics, Inc. | 2010-08-30 | 194 | 1 |
| K100502 | ASCENSION TOTAL PLATE SYSTEM | Ascension Orthopedics, Inc. | 2010-08-02 | 161 | 0 |
| K100925 | ASCENSION ANKLE FUSION NAIL SYSTEM | Ascension Orthopedics, Inc. | 2010-07-12 | 101 | 0 |
| K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM | Ascension Orthopedics, Inc. | 2010-06-16 | 146 | 0 |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | Ascension Orthopedics, Inc. | 2010-01-14 | 192 | 0 |
| K092440 | ASCENSION CANNULATED SCREW SYSTEM | Ascension Orthopedics, Inc. | 2009-11-05 | 87 | 0 |
| K082231 | ASCENSION SILICONE PIP | Ascension Orthopedics, Inc. | 2009-01-12 | 158 | 0 |
| K080997 | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | 2008-06-17 | 70 | 0 |
| K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/H | Ascension Orthopedics, Inc. | 2007-06-22 | 67 | 0 |
| K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM | Ascension Orthopedics, Inc. | 2006-10-31 | 36 | 0 |
| K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-4 | Ascension Orthopedics, Inc. | 2006-08-11 | 78 | 1 |
| K060560 | ASCENSION PYROSPHERE CMC/TMT | Ascension Orthopedics, Inc. | 2006-05-05 | 64 | 1 |
| K052137 | ASCENSION MUH | Ascension Orthopedics, Inc. | 2005-11-03 | 90 | 0 |
| K042690 | ASCENSION PYROSPHERE (PCS) | Ascension Orthopedics, Inc. | 2004-11-13 | 45 | 0 |
| K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS | Ascension Orthopedics, Inc. | 2004-08-25 | 85 | 2 |
| K032686 | ASCENSION MODULAR RADIAL HEAD | Ascension Orthopedics, Inc. | 2003-10-22 | 54 | 0 |
| K022892 | ASCENSION SILLICONE MCP | Ascension Orthopedics, Inc. | 2002-11-25 | 87 | 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