(62 days)
The Biomet® Vision® Foot Ring System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Additional indications include:
- Correction of deformity .
- Revision procedures where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction and Lisfranc dislocations
- Ankle distraction (arthrodiastasis)
Device Desertification. and K052239.
This submission is a 510(k) Premarket Notification for the Biomet® Vision® Foot Ring System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for acceptance criteria.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves the device meets specific performance metrics.
Instead, the document states:
- The Biomet Trauma device is substantially equivalent to other legally marketed devices, specifically the Stryker Hoffman II Foot Ring (K041706) and the SBi RingFIX™ System (K071394).
- The "Operational principles for the device are unchanged." (from the previously cleared device)
The FDA's letter further confirms that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
In summary, none of the requested information (1-9) about acceptance criteria, study design, sample sizes, ground truth establishment, or human reader performance is present in this 510(k) summary because it is not typically required for a substantial equivalence determination for this type of device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.