Newclip Patient-matched instrumentation non sterile PSI
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250767 FDA 510(k)
- FDA Product Code
- PBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Newclip Patient-matched Instrumentation Non-sterile PSI is classified as an Orthopaedic Surgical Planning and Instrument Guide (OpenFDA: PBF). These devices are patient-specific, additively manufactured surgical guides designed to assist in pre-operative planning and intraoperative guidance for distal tibial osteotomies, including medial opening or closing wedge procedures and lateral closing wedge osteotomies. They are engineered to match individual patient anatomy, ensuring precision during surgical interventions.
Supplied non-sterile, these guides are intended for single-use in orthopedic settings. Each device is printed, cleaned, and packaged prior to shipment. Authorized under FDA 510(k) clearance (K250767) as substantially equivalent, they fall under device class II (regulation number 888.3030) and are regulated for orthopedic use. No third-party review was required for this submission.
Frequently asked questions
What is the Newclip Patient-matched Instrumentation Non-sterile PSI used for?
This device is designed for pre-operative planning and intraoperative guidance during distal tibial osteotomies, specifically for medial opening or closing wedge procedures and lateral closing wedge osteotomies. The patient-matched, additively manufactured guides ensure precise alignment by matching individual patient anatomy, reducing surgical variability and improving outcomes.
How is the Newclip Patient-matched Instrumentation Non-sterile PSI supplied and intended for use?
The device is supplied non-sterile and is intended for single-use only in orthopedic settings. Each guide is printed, cleaned, and packaged before shipment to ensure readiness for surgical use. Sterilization is not required prior to use, as the device is designed for one-time application.
Are there multiple sizes or models available for this device?
Yes, this device comes in multiple models, each corresponding to specific patient anatomy and surgical requirements. The listed OpenFDA registration numbers (e.g., 3027329005, 3014273501) indicate distinct configurations for different distal tibial osteotomy procedures, ensuring compatibility with a range of clinical scenarios.
How should the Newclip Patient-matched Instrumentation Non-sterile PSI be stored before use?
The device should be stored in its original, sealed packaging to maintain cleanliness and integrity. Since it is non-sterile and single-use, avoid exposure to contaminants or moisture. Follow manufacturer instructions for proper handling to ensure the guide remains functional and safe for its intended surgical application.
What regulatory pathway was followed for this device?
The Newclip Patient-matched Instrumentation Non-sterile PSI was cleared through the FDA 510(k) pathway under clearance number K250767, with a decision of Substantially Equivalent (SESE). It falls under device class II (regulation number 888.3030) and is regulated for orthopedic use, with no third-party review required for this submission.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Newclip Patient-matched instrumentation non sterile PSI (K250767) — FDA ..., PSI - Patient Solution Specific - Newclip Technics, PDF Robert A. Poggie, PhD President BioVera, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250767 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newclip Technics
Sources (1)
- FDA 510(k) K250767 24 fields · synced Oct 1, 2026