(79 days)
The 4.0 mm Cannulated Screws and associated washers are indicated for arthrodesis and osteotomies of small bones and small joints, and ankle fracture.
The 5.5 mm. 6.5 mm. 7.0 mm. and 8.0 mm Cannulated Screws. Cannulated Hip Pins and associated washers are indicated for fracture fixation, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device.
The Smith & Nephew 2.5 mm, 3.0 mm Headless Compression Screws are indicated for fixation of fractures, bunionectomies and osteotomies of small bones, and arthrodesis of small joints.
The Smith & Nephew 2.0 mm QFX Screw is indicated for osteotomies of the lesser metatarsals, and osteotomies and fractures of the phalanges.
The subject Cannulated Screw System includes the 2.0 QFX Screw, 2.5mm and 3.0mm Headless Compression Screws, 4.0mm, 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated Washers (K090675, K111994, K213126).
The Smith & Nephew Cannulated Screw System consists of stainless steel (316L conforming to ASTM F139 and ISO 5832-1 or titanium (Ti-6Al-4V conforming to ASTM F1472/SO 5832-3) implantable devices of many styles for use in fracture fixation. The Smith & Nephew Cannulated Screws product family includes Large Cannulated Screws, Cannulated Hip Pins, Hip Screws, QFX Screws, and associated Washers. The components are available in various diameters, thread options, and lengths. All screws are designed with a self-drilling, self-tapping tip to facilitate easy implantion with a reverse cutting flute design to assist with implant removal. Select screws are designed with low-profile screw heads for reduced soft tissue irritation, and 3.0mm and 7.0mm screws are available headless.
The implants within this system are single-use and are Gamma sterilized.
The provided text is a 510(k) summary for a "Cannulated Screw System" and details that the submission is for labeling updates, specifically updated indications for use. The critical information here is that there are no changes to the device's design, technological characteristics, function, sterilization, or packaging.
Therefore, the submission explicitly states: "no performance testing (bench, animal, clinical) was required." This means there is no study described in this document that proves the device meets specific acceptance criteria based on performance. The clearance is based on the substantial equivalence of the device itself (which was previously cleared) and the fact that the labeling changes do not impact safety or effectiveness.
Because no performance study was conducted for this specific submission, I cannot fill in the requested table and information points.
Here's a breakdown of why based on the input:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. No performance study was conducted.
- 2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance study was conducted.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a screw system, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a screw system, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study was conducted.
- 8. The sample size for the training set: Not applicable. No machine learning training was performed.
- 9. How the ground truth for the training set was established: Not applicable. No machine learning training was performed.
The core of this 510(k) submission is to update the indications for use based on existing, cleared devices, implying that the safety and effectiveness have already been established through prior submissions for functionally identical devices. The changes are specifically for "user clarification" of the indications.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.