MedShape, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “MedShape, Inc.” (first 2012, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 137 days. Since 2017 the median was 144 days, against 94 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 64 |
| 2013 | 3 | 127 |
| 2014 | 2 | 168 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 176 |
| 2018 | 1 | 125 |
| 2019 | 1 | 141 |
| 2020 | 1 | 146 |
| 2021 | 1 | 59 |
| 2022 | 2 | 271 |
| 2023 | 0 | — |
| 2024 | 1 | 27 |
| 2025 | 1 | 193 |
| 2026 | 1 | 89 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name MedShape, Inc. took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 6 | 6 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 3 |
| JDR | Staple, Fixation, Bone | 3 | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 | 3 |
| HTN | Washer, Bolt Nut | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent MedShape, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | HWC | 2026-03-18 | 89 |
| K250628 | DynaNail TTC Fusion System | HSB | 2025-09-12 | 193 |
| K240530 | DynaNail Mini Tapered Hybrid | HWC | 2024-03-21 | 27 |
| K220812 | DynaClip® Bone Staple | JDR | 2022-08-19 | 151 |
| K203595 | DynaFuse Fixation System | HWC | 2022-01-04 | 391 |
| K203381 | Dynanail Mini Hybrid | HWC | 2021-01-15 | 59 |
| K193305 | DynaClip Bone Staple | JDR | 2020-04-23 | 146 |
| K182677 | DynaNail Mini | HWC | 2019-02-14 | 141 |
| K181781 | DynaClipTM Bone Staple | JDR | 2018-11-05 | 125 |
| K171376 | DynaNail TTC Fusion System | HSB | 2017-11-02 | 176 |
6 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-06-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medshape Solutions (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under MedShape, Inc.?
FDA lists 16 510(k) clearances under the applicant name “MedShape, Inc.” (first 2012, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by MedShape, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name MedShape, Inc. is 137 days. Since 2017: 144 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under MedShape, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 6); HSB (Rod, Fixation, Intramedullary And Accessories, 3); JDR (Staple, Fixation, Bone, 3).
Next steps
- See all 16 MedShape, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, MedShape, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.