(29 days)
The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
The Nextremity Solutions 3.4mm FlexFusion™ Fixation implant system consists of a two-part 3.4mm diameter bone fixation implant. The proximal and distal components are provided as a set and as a procedure pack with the necessary surgical site preparation and insertion instruments. The Nextremity Solutions FlexFusion™ Fixation Implant is fabricated from medical grade stainless steel and the design allows the clinician to establish a natural angulation of the fused inter-digital joint.
The sponsor, Nextremity Solutions, LLC, did not provide acceptance criteria and a study to prove that the device meets the acceptance criteria. The 510(k) K110445 outlines that the device is substantially equivalent to the predicate device Arthrex Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) [510(k) K050259]; Smooth or threaded bone fixation fasteners, StayFuse™ Fixation implant [510(k) Number K990804]; FlexFusion™ Fixation implant and NEWDEAL K Wire [501(k) K022599]; Memometal Intramedullary Arthrodesis Device [510(k) K070598]. This is based on the following:
- Intended Use: The device shares the same intended use.
- Basic Design: The device has a similar basic design.
- Material: The device is fabricated from medical grade stainless steel, similar to predicate devices.
- Size: The device is of comparable size (3.4mm diameter).
- Fundamental Technology: The device utilizes similar fundamental technology for bone fixation.
Performance Data:
Mechanical testing was performed for the Nextremity Solutions FlexFusion™ Fixation implant. This testing included:
- Pull-out force: To assess the force required to remove the implant from bone.
- Driving torque: To evaluate the torque needed to insert the implant.
- Torque to failure: To determine the maximum torque the implant can withstand before failure.
- Static and dynamic flexion extension resistance: To assess the implant's resistance to bending and movement under different conditions.
In addition to mechanical testing, results from cadaver test labs were also presented to support the performance of the device.
No information was provided regarding:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for any test set or data provenance.
- The number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone performance studies (i.e., algorithm only without human-in-the-loop performance).
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- The sample size for any training set.
- How ground truth for any training set was established.
§ 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.