Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MedShape, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
283 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; Dy | MedShape, Inc. | 2026-03-18 | 89 | 0 |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 2025-09-12 | 193 | 0 |
| K240530 | DynaNail Mini Tapered Hybrid | MedShape, Inc. | 2024-03-21 | 27 | 0 |
| K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022-08-19 | 151 | 0 |
| K203595 | DynaFuse Fixation System | MedShape, Inc. | 2022-01-04 | 391 | 0 |
| K203381 | Dynanail Mini Hybrid | MedShape, Inc. | 2021-01-15 | 59 | 0 |
| K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020-04-23 | 146 | 0 |
| K182677 | DynaNail Mini | MedShape, Inc. | 2019-02-14 | 141 | 0 |
| K181781 | DynaClipTM Bone Staple | MedShape, Inc. | 2018-11-05 | 125 | 0 |
| K171376 | DynaNail TTC Fusion System | MedShape, Inc. | 2017-11-02 | 176 | 0 |
| K141420 | FASTFORWARD | MedShape, Inc. | 2014-12-18 | 203 | 0 |
| K141290 | HELICAL RIDGE PEEK INTERFERENCE SCREW | MedShape, Inc. | 2014-09-29 | 133 | 0 |
| K132783 | EXOSHAPE DUO SOFT TISSUE FASTENER | MedShape, Inc. | 2013-12-09 | 94 | 0 |
| K130467 | POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE | MedShape, Inc. | 2013-12-05 | 283 | 0 |
| K123350 | ECLIPSE SOFT TISSUE FASTENER | MedShape, Inc. | 2013-03-07 | 127 | 0 |
| K113828 | DYNANAIL ANKLE ARTHRODESIS NAIL | MedShape, Inc. | 2012-02-29 | 64 | 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