(218 days)
Uni-FuZe-C Bone Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Uni-FuZe-C Bone Strip resorbs and is replaced with bone during process.
Zavation Medical's Uni-FuZe-C Bone Strip is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute in strip form. The product is composed of a matrix of purified bovine collagen per ASTM F2212, beta tricalcium phosphate (Beta-TCP per ASTM F1088), and Bioglass 45S5 per ASTM F1538.
The provided text describes the 510(k) summary for Zavation Uni-FuZe-C Bone Strip (K221726) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study directly proving the device meets those criteria in a typical AI/software context.
However, based on the information provided, we can infer performance criteria related to the device's biological and physical characteristics and how they were evaluated.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from regulatory requirements and testing) | Reported Device Performance (Summary of results) |
|---|---|---|
| Biocompatibility | Acceptable biological safety profiles (per ISO 10993-1:2018 and FDA Guidance) | Demonstrated acceptable biological safety profiles (Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Systemic reaction, Implantation tests). |
| Material Composition | Meeting specific ASTM standards for constituents | Bioactive glass, collagen, and ß-TCP constituents tested and/or certified to meet ASTM F2212, ASTM F1538, and ASTM F1088 requirements. |
| Biological Performance (In-vivo) | Normal osteoconductive healing response; absence of adverse inflammatory reactions; substantially equivalent performance to predicate. | Macro observations showed healthy tissue absent of adverse inflammatory reactions. Radiographic and microCT analyses indicated no adverse reactions and a normal progression in healing. Histopathology showed normal osteoconductive healing response. Demonstrated substantially equivalent in vivo performance to the primary predicate device across all endpoints. |
| Bioactivity | Precipitation of apatite during in-vitro assessment (per ISO 23317) | Determined to be bioactive per ISO 23317, with bioactive glass granules precipitating apatite in SBF. |
| Packaging Integrity | Meeting acceptance criteria for seal strength and integrity | Packaging seal strength and integrity validated via peel strength (ASTM F88/F88M) and bubble emission (ASTM F2096); acceptance criteria were met. |
| Shipping & Handling | Meeting acceptance criteria for shipping and handling validation | Shipping and handling validations performed per ASTM D7386; acceptance criteria were met. |
| Shelf Life | Validated for the specified duration | Shelf life validated for one-year. |
| Sterilization | Meeting specified SAL and endotoxin levels | Sterilization validated to SAL of 10° using VDmax method per ANSI/AAMI/ISO 11137-2: 2013/(R)2019 with 25 kGy minimum dose. LAL testing showed |
§ 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.