Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Centerpulse Orthopedics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
304 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033943 | ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND | Centerpulse Orthopedics, Inc. | 2004-10-18 | 304 | 0 |
| K033634 | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED | Centerpulse Orthopedics, Inc. | 2004-09-15 | 301 | 2 |
| K040947 | DURASUL BIPOLAR | Centerpulse Orthopedics, Inc. | 2004-08-27 | 137 | 0 |
| K033810 | NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM | Centerpulse Orthopedics, Inc. | 2004-03-05 | 88 | 1 |
| K033664 | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STE | Centerpulse Orthopedics, Inc. | 2003-12-17 | 26 | 1 |
| K032348 | CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP | Centerpulse Orthopedics, Inc. | 2003-10-24 | 86 | 0 |
| K030923 | EPSILON DURASUL CONSTRAINED ACETABULAR LINER | Centerpulse Orthopedics, Inc. | 2003-10-03 | 193 | 0 |
| K032380 | WAGNER CONE PROSTHESIS | Centerpulse Orthopedics, Inc. | 2003-09-22 | 52 | 0 |
| K031183 | TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIA | Centerpulse Orthopedics, Inc. | 2003-07-14 | 90 | 0 |
| K030373 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM | Centerpulse Orthopedics, Inc. | 2003-03-06 | 30 | 1 |
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