Starr Frame Steinmann Pin
by Starr Frame LLC United States EUDAMED510(k)
510(k) K082017
Product code HTY
Overview
The Starr Frame Steinmann Pin is classified as an Orthopedic Fixation Device, specifically a type of intramedullary pin used for internal fixation of long bones. It is designed to stabilize fractures by providing rigid alignment and support during the healing process, ensuring proper bone alignment and facilitating skeletal restoration.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K082017) and MDR, with a substantially equivalent determination to predicate devices. The pins are manufactured by Starr Frame LLC and are intended for use in orthopedic procedures, adhering to strict regulatory standards for orthopedic hardware. No additional context regarding MRI safety, sizes, or storage conditions is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK082017 | Date10 Oct 2008 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- HTY
- FDA applicant
- Starr Frame, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Starr Frame LLC
Questions
What types of fractures is the Starr Frame Steinmann Pin designed to stabilize, and how does it work?
The Starr Frame Steinmann Pin is an intramedullary orthopedic fixation device intended for internal stabilization of long bone fractures. It provides rigid alignment and support during the healing process by being inserted into the medullary cavity of the bone, effectively holding fracture fragments in place to promote proper skeletal restoration and alignment.
Is the Starr Frame Steinmann Pin meant for reuse, or is it single-use only?
The Starr Frame Steinmann Pin is explicitly supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or contamination associated with reuse.
How is the regulatory status of this device determined, and what does that mean for its use?
The Starr Frame Steinmann Pin holds an FDA 510(k) clearance (K082017) with a determination of substantial equivalence to predicate devices, meaning it has been reviewed and approved as safe and effective for its intended use as an orthopedic fixation device. It also complies with the EU Medical Device Regulation (MDR).
Who manufactures the Starr Frame Steinmann Pin, and where can I find contact information for the company?
The device is manufactured by Starr Frame LLC, headquartered at 1302 E. Collins Blvd., Richardson, TX 75081, USA. For inquiries, you may contact Frank Gerome, though it’s best to verify current contact details directly with the manufacturer.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K082017
- EUDAMED