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The 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.

The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® PLS Implant may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm BONE-LOK® PLS Implant.

The 4.5mm BONE-LOK® PLS Implant is a double-helix screw with a compressionlocking collar made of medical grade titanium alloy and is provided "STERILE". The Single use PERPOS™ PLS System contains the 4.5mm BONE-LOK® PLS Implant and disposable surgical instruments for use in implanting the device and is provided "STERILE". The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclave) and is performed on-site.

The provided text is a 510(k) summary for a medical device (Single Use PERPOS™ PLS System, BONE-LOK® PLS Implant). It describes the device, its intended use, and claims substantial equivalence to predicate devices.

However, the document does NOT contain any information regarding acceptance criteria, study details, or performance data of the device.

The document discusses:

• Device Identification: Trade names, common names, classification, product codes.
• Predicate Devices: Lists previously cleared devices to which the current device claims substantial equivalence.
• Device Description: Materials and general characteristics of the implant and associated instruments.
• Intended Use/Indications for Use: Specifies the medical conditions the implant is used for and its role in spinal fusion.
• Technological Characteristics and Substantial Equivalence: Asserts that the device is similar to predicates in these aspects.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information, which includes a table of acceptance criteria and device performance, sample sizes for test and training sets, data provenance, ground truth establishment, expert details, adjudication methods, or results of MRMC or standalone studies.

The 510(k) pathway for medical device clearance in the US primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies against predefined acceptance criteria for novel device functions. Performance data, if present, would typically be found in more detailed sections of the 510(k) submission, which are not included in this publicly available summary.

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