Medshape, INC.
FDA Regulatory Profile
Medshape, INC. appears in FDA public data with 2 recalls, 16 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2513-2025, Class II) was initiated on Jun 2, 2025. Its most recent 510(k) clearance was granted on Mar 18, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 16
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2513-2025 | Class II | Medshape Universal Joints, REF: DNE-9000-UJ | Jun 2, 2025 |
| Z-0453-2022 | Class II | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile | Nov 17, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Q | Mar 18, 2026 |
| K250628 | DynaNail TTC Fusion System | Sep 12, 2025 |
| K240530 | DynaNail Mini Tapered Hybrid | Mar 21, 2024 |
| K220812 | DynaClip® Bone Staple | Aug 19, 2022 |
| K203595 | DynaFuse Fixation System | Jan 4, 2022 |
| K203381 | Dynanail Mini Hybrid | Jan 15, 2021 |
| K193305 | DynaClip Bone Staple | Apr 23, 2020 |
| K182677 | DynaNail Mini | Feb 14, 2019 |
| K181781 | DynaClipTM Bone Staple | Nov 5, 2018 |
| K171376 | DynaNail TTC Fusion System | Nov 2, 2017 |
| K141420 | FASTFORWARD | Dec 18, 2014 |
| K141290 | HELICAL RIDGE PEEK INTERFERENCE SCREW | Sep 29, 2014 |
| K132783 | EXOSHAPE DUO SOFT TISSUE FASTENER | Dec 9, 2013 |
| K130467 | POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE | Dec 5, 2013 |
| K123350 | ECLIPSE SOFT TISSUE FASTENER | Mar 7, 2013 |
| K113828 | DYNANAIL ANKLE ARTHRODESIS NAIL | Feb 29, 2012 |