Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)
510(k) K110805
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110805 | Date21 Jun 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OBT
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Plate, Bone, Growth Control, Pediatric, Epiphysiodesis, classified as a Class II medical device under FDA regulations. It consists of stainless steel eight-plate and quad-plate constructs designed to gradually correct pediatric bone deformities, including congenital or acquired lower extremity malformations. The system utilizes controlled growth modulation to guide skeletal alignment without full fusion, preserving future growth potential. Its primary function is to apply targeted pressure to the growth plate, enabling gradual angular correction over time.
The Guided Growth System Eight-Plate and Quad-Plate are supplied in sterile or non-sterile configurations, intended for surgical use in orthopedic settings. Each plate is paired with cannulated or solid screws of varying sizes to accommodate different anatomical requirements. The system is regulated under FDA 510K clearance (K110805) as substantially equivalent to a predicate device, adhering to regulatory standards for orthopedic implants. Storage and handling follow standard sterile surgical protocols, with device specifications listed under regulation number 888.3030.
Other devices from Orthofix, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Guided Growth System Eight-Plate and Quad-Plate?
The system is designed to gradually correct pediatric bone deformities, such as congenital or acquired lower extremity malformations, by applying controlled pressure to the growth plate. This targeted approach enables gradual angular correction without permanently fusing the bone, thereby preserving future growth potential.
How is the Guided Growth System supplied, and what does this mean for surgical use?
The system is available in both sterile and non-sterile configurations, tailored for surgical use in orthopedic settings. Sterile configurations ensure infection control during procedures, while non-sterile options may be used in settings where immediate sterility is not required, though they must be sterilized prior to use following standard surgical protocols.
Are the plates reusable, or are they intended for single-use?
The Guided Growth System Eight-Plate and Quad-Plate are designed for single-use. Reuse is not recommended due to potential risks of contamination, corrosion, or loss of structural integrity, which could compromise patient safety and treatment outcomes.
What types of screws are included with the system, and how do they accommodate anatomical variations?
The system pairs each plate with cannulated or solid screws of varying sizes. Cannulated screws allow for precise placement and potential future adjustments, while solid screws provide stability for specific anatomical requirements. This modularity ensures adaptability to different patient anatomies and surgical needs.
How should the Guided Growth System be stored, and what regulatory standards apply?
The system must be stored according to standard sterile surgical protocols if in sterile configuration. Non-sterile plates must be sterilized prior to use. Storage adheres to FDA regulation number 888.3030, which governs bone growth control devices, ensuring compliance with orthopedic implant standards.