(35 days)
The JGHI Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the JGHI Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
The JGHI Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments.
This document is an FDA 510(k) clearance letter for the AgNovos Healthcare USA, LLC's JGH1 Core Decompression Procedure Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI effectiveness studies.
The letter primarily focuses on:
- Granting FDA clearance for the JGH1 Core Decompression Procedure Kit (K181585).
- Identifying the device, its regulation number, and product code.
- Stating the Indications for Use for the device, which are "during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the JGHI Core Decompression Procedure Kit is not intended to be used as a load-bearing device."
- Outlining general regulatory requirements that the manufacturer must still comply with.
Therefore, I cannot provide the requested information based on the provided text. The detail you are asking for would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which are part of this FDA clearance letter.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.