RxG Distraction System
510(k) K150771
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150771 | Date27 Aug 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBJ
- FDA applicant
- KLS Martin L.P.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5330
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The RxG Distraction System is a cranial distraction system designed for distraction osteogenesis, enabling controlled bone elongation and stabilization in the correction of congenital or developmental midface and alveolar ridge defects. It falls under the classification of a Class II medical device, as defined by the FDA’s product code PBJ, and is intended for use in both pediatric and adult cranial reconstruction procedures. The system facilitates gradual bone lengthening through mechanical distraction, promoting natural bone growth and remodeling in targeted skeletal regions.
This system is supplied as a sterile, implantable device comprising resorbable poly(L-lactide-co-glycolide) (PLLA/PGA) footplates, a titanium alloy (Ti-6Al-4V) or stainless steel threaded drive screw, and an activation arm. It is intended for single-use in controlled surgical settings, adhering to FDA 510(k) clearance (K150771) under the Neurology advisory committee. Proper storage and handling are critical to maintain sterility and functionality, with regulatory compliance ensured through the manufacturer’s adherence to FDA guidelines for cranial distraction devices.
Other devices from KLS-Martin L.P.
Questions
AI-generated answers, 20 Sep 2026
What types of bone defects is the RxG Distraction System specifically designed to address in cranial reconstruction procedures?
The RxG Distraction System is designed for distraction osteogenesis to correct congenital or developmental midface and alveolar ridge defects. It enables controlled bone elongation and stabilization through mechanical distraction, promoting natural bone growth and remodeling in targeted skeletal regions, which is particularly useful in both pediatric and adult cranial reconstruction cases.
Is the RxG Distraction System reusable, or is it intended for single-use only?
The RxG Distraction System is explicitly intended for single-use in controlled surgical settings. This ensures sterility and functionality are maintained, as reusing implantable devices can compromise patient safety and regulatory compliance.
What materials are used in the construction of the RxG Distraction System, and how does this affect its functionality?
The system includes resorbable poly(L-lactide-co-glycolide) (PLLA/PGA) footplates for gradual integration with bone, a threaded drive screw made of either titanium alloy (Ti-6Al-4V) or stainless steel for durability and stability, and an activation arm for mechanical distraction. These materials ensure controlled bone elongation while maintaining structural integrity during the distraction process.
How should the RxG Distraction System be stored to maintain its sterility and functionality?
The RxG Distraction System is supplied as a sterile implantable device, so proper storage and handling are critical. It must be stored in a way that preserves sterility—typically in a sealed, sterile packaging—until ready for surgical use. Adherence to manufacturer guidelines ensures compliance with FDA regulations and maintains the device’s functionality for distraction osteogenesis.
What regulatory pathway was followed for FDA clearance of the RxG Distraction System, and which advisory committee was involved?
The RxG Distraction System received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent under product code PBJ. The Neurology advisory committee (NE) was involved in the review, ensuring the device met regulatory standards for cranial distraction systems in neurology-related procedures.