ARTHROVIMS ANCHOR LRP

Trade name

ARTHROVIMS ANCHOR LRP

18904210319886

B-18904210319886

Reference / catalog number

VIMS-9092.55F

GS1

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

ArthroVIMS ANCHOR LRP Ligament Anchor, PEEK Knotless, Dia. 5.5mm

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P09120102ANCHORS, TENDON AND LIGAMENT SYNTHESIS

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Foreign body sensitivity or Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to Acute or chronic local or systemic infection. implantation. Patient conditions including Blood supply limitation and previous infections which may tend to retard healing. Insufficient quantity or quality of bone or soft tissue. Anchor performance is directly related to the quality of bone or soft tissue into which the anchor is placed. Pathological conditions of bone & soft tissue, such as cystic changes, tumor or severe osteopenia, which would compromise secure implant fixation. Comminuted bone surface, which would compromise secure implant fixation. Severe muscular, nervous, and/or vascular disorders that could endanger the limb. Any concomitant illness and/or dependence that could risk implanting function. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate. Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions. Conditions which tend to limit the patient's ability or willingness to restrict activities or follow the surgeon's prescribed post-operative regimen during the healing period. Any situation that would compromise the ability of the user to follow the instructions for use or using the device for an indication other than those listed. Excessive body activities that could cause overloading of the implant.