Medshape Solutions
Country not established
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Medshape Solutions makes
Medshape Solutions manufactures orthopedic fixation devices, including soft tissue fasteners for ligament repair such as cruciate ligament and tenodesis applications, suture anchors with integrated Opti-Fiber sutures for tendon or ligament reattachment, and locking screws with deployment frames for bone stabilization. Their portfolio also includes interference fixation devices designed for secure bone-to-bone attachment in joint procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance pathway. Their products are intended for use in the United States, where they comply with applicable medical device standards and manufacturing requirements.
Catalogue
Shapeloc-Cl (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-St (Tenodesis) Soft Tissue Fastner Ref K101808
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Wedgeloc 180X Standard Suture Anchor With Opti Fiber Sutures, Model 1000-01 Tab Varying Diameters, Ref K091202
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Medshape Solutions, initiated on 2013-04-04. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 4 Apr 2013 Z-1276-2013 Class II Terminated Expiration date on the patient label and date on the product carton were not the same.
Frequently asked questions
How many devices does Medshape Solutions have in the registry?
The registry currently lists 6 devices for Medshape Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medshape Solutions's devices?
Among its 6 most recently registered devices, Medshape Solutions has devices listed in FDA 510(k) (6 devices).
What risk classes do Medshape Solutions's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Medshape Solutions's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medshape Solutions?
FDA recall records list 1 recall initiated by Medshape Solutions, the most recent initiated on 2013-04-04. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medshape Solutions in the registry?
The most recently registered devices listed for Medshape Solutions include SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER, WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES, DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 and WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES, MODEL 1000-01 TAB VARYING DIAMETERS,.