Medshape Solutions: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medshape Solutions” (first 2009, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 3 | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Medshape Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101934 | DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 | HSB | 2011-08-03 | 387 |
| K111471 | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) | MBI | 2011-06-10 | 14 |
| K101808 | SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER | HWC | 2010-11-08 | 132 |
| K092914 | WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES | MBI | 2009-12-09 | 78 |
| K091202 | WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, | HWC | 2009-09-16 | 145 |
| K083792 | WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 | HWC | 2009-03-25 | 96 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-04-04.
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, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medshape Solutions?
FDA lists 6 510(k) clearances under the applicant name “Medshape Solutions” (first 2009, latest 2011), across 3 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 Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medshape Solutions is 114 days.
Which FDA product codes appear under Medshape Solutions?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 3); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Next steps
- See all 6 Medshape Solutions clearances with predicates and recalls
- Run predicate analysis for product code HWC, Medshape Solutions'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.