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EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only.

BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality.

Examples of small and long bone indications for which BITE Compression screws are used:

• Minimally invasive fracture/joint reconstructions
• Multiple-fragment joint fractures
• Simple epiphyseal fractures
• Fractures of the head of the humerus
• Fractures of the head of the tibia
• Cooper fractures of the tibia
• Fractures of the radius
• Fractures of the wrist, ankle, elbow and shoulder
• Scaphoid fractures and other fractures of the hand
• Metatarsal fractures and other fracture of the foot
• Ligament fixation of the proximal humerus
• Ligament avulsion injuries (Apohysis)
• Fractures of small joint bones
• Malleolar fractures
• Navicular fractures
• Fractures of the calcaneus and talus
• Arthrodesis of the ankle joint
• Avulsion fracture and metatarsal V
• Fractures of the tarsal region
• Osteotomies

BITE Compression Screws are not intended for use in the spine.

The EDGE Orthopaedics BITE™ Compression Screws include sterile titanium self- drilling and self- tapping screws. The corresponding instrumentation (depth gauges, forceps, screwdrivers, retractors, and tenaculums) to facilitate insertion is found in EDGE's RIVAL™ Instrument Tray. The cannulated compression screws are offered in a variety of diameters and lengths designed for the temporary fixation, correction or stabilization of bones. The unique low profile head design, cutting characteristics and vast screw options of the BITE Compression Screws provides extensive versatility in one comprehensive system.

The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria, as it pertains to a bone screw device, not an AI or diagnostic device that would typically have such studies described in this format.

The document is a 510(k) summary for the EDGE Orthopaedics BITE™ Compression Screw, which is a medical device for bone fixation. The safety and effectiveness of this device were determined through substantial equivalence to predicate devices, material information, and test results, rather than clinical data or performance metrics like sensitivity/specificity often associated with AI/diagnostic tools.

No information is available regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance.
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The "Performance Data" section explicitly states: "The safety and effectiveness of the EDGE Orthopaedics BITE™ Compression Screws are adequately supported by the substantial equivalence information, materials information and test results provided within this Premarket Notification."

The "Clinical Data" section explicitly states: "Clinical data was not used to determine substantial equivalence."

This indicates that the FDA clearance was based on non-clinical performance testing (e.g., mechanical tests, materials testing) and demonstrating similarity to already approved devices, not on a study with human readers, AI algorithms, or clinical performance metrics as implied by the request's structure.

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