Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HSH — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
95 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073233 | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | Advanced Bio-Surfaces, Inc. | 2008-01-28 | 74 | 0 |
| K053094 | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063 | Advanced Bio-Surfaces, Inc. | 2006-02-06 | 95 | 0 |
| K033242 | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | Imaging Therapeutics, Inc. | 2003-12-31 | 85 | 0 |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | Osteoimplant Technology, Inc. | 2002-11-20 | 90 | 0 |
| K003269 | UNICONDYLAR INTERPOSITIONAL SPACER | Sulzer Orthopedics, Inc. | 2001-01-04 | 78 | 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