Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medshape Solutions · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
387 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101934 | DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNN | Medshape Solutions | 2011-08-03 | 387 | 0 |
| K101808 | SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELO | Medshape Solutions | 2010-11-08 | 132 | 0 |
| K092914 | WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH O | Medshape Solutions | 2009-12-09 | 78 | 0 |
| K091202 | WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES | Medshape Solutions | 2009-09-16 | 145 | 0 |
| K083792 | WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-0 | Medshape Solutions | 2009-03-25 | 96 | 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