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The Lorenz Resorbable Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) when correction of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects require gradual bone distraction. The Lorenz Resorbable System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of mandibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger. The mid-face distractor is indicated primarily for LeFort III osteotomies.

This distractor system is identical to the one cleared in 510(k) Premarket Notification (K002083). This device is composed of the same Lactosorb® end plates and fixation screws, and stainless steel drive screws with the added indication of mandibular distraction. The Mandibular Distractor is the same as our previously cleared Alveolar Ridge Resorbable Distractor (K002083) with the added indication of mandibular distraction. The Alveolar Ridge Resorbable Distractor is an implantable device used to increase the height of the maxilla or mandible or to replace bone in the Alveolar Ridge, used for multiple tooth deficiencies. This device is composed of two resorbable plates and a stainless steel drive screw. Several lengths of drive screw can be selected to achieve up to 25 mm of distraction. The Mandibular Distractor can incorporate either of the two Alveolar Ridge resorbable devices with no design changes. In addition, a third device is included that is identical to the two Mandibular or Ramus lengthening devices with no design changes. Each device is composed of two resorbable Alveolar Ridge resorbable plates and a stainless steel drive screw with permanently attached shaft extension. The devices would be positioned internally with drive screws externalized on the external activated side of the advancement. Complete osteotomy would be completed prior to device placement. Lactosorb plates would be affixed to bone using Lactosorb screws. Distraction would be completed by turning the drive screw using the attached shaft extension, causing the plates to separate. After distraction and consolidation, the drive shaft is detached from the plates and removed while the plates and screws remain internal and are resorbed.

Walter Lorenz Surgical, Inc. manufactures and distributes distraction devices for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxillofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb® resorbable connection plates, which are implanted by fixation with LactoSorb® bone screws. Each device is made from one of the following material(s): LactoSorb®, Titanium 6Al 4V Alloy, ASTM F-136, Stainless Steel, ASTM F-138. LactoSorb® is a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into lactic and glycolic acids that are then metabolized by the body.

This document is a 510(k) Premarket Notification for the Lorenz Resorbable Distraction System, which means it's a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report that establishes performance criteria through testing and provides acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a previously cleared device (K002083 and others) rather than presenting new performance data from a specific study.

The document states:

• "This distractor system is identical to the one cleared in 510(k) Premarket Notification (K002083)." (Page 0)
• "The Mandibular Distractor is the same as our previously cleared Alveolar Ridge Resorbable Distractor (K002083) with its added indication of mandibular distraction." (Page 0)
• "Lactosorb® Biocompatibility has been provided by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K981666, K960988) for cranial and maxillofacial use." (Page 0)
• The "Substantial Equivalence" section lists other Lorenz Distraction Systems and Resorbable Fixation Screws and Plates as comparators. (Page 1)

These statements indicate that the submission relies on the established safety and effectiveness of the predicate devices. The listed "RELATED ARTICLES" are general academic papers on distraction osteogenesis and resorbable fixation, not specific studies conducted by the manufacturer for this particular 510(k) submission to establish new performance metrics.

In summary, the provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or ground truth for a test set.
3. Details about expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
4. Information on training set size or how its ground truth was established, as this is not a machine learning device.

The document is a regulatory submission demonstrating equivalence, not a detailed technical report of a performance study.

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