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The Lorenz Orthodontic Anchorage System implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.

The Walter Lorenz Surgical Orthodontic Anchorage System is comprised of a variety of plates and screws designed to provide anchorage for orthodontic procedures.

Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

The Lorenz Titanium Fracture / Rexastructive Devices are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for neassion of modition of marco on a varior of manum natures. The screws have both cross drive and canter dive head features, lag sames and as males will includes will includes straight, angle, double angle, and crescent, options with various lengths and thickness. The Lorenz Titanium Fracture / Reconstructive Pre-Bent Plates are comprised of a specific range of existing plates. The plate is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient. The Pro-batt plates may, in special cases, be attached to our Temporary Add-on Condyle (cleared under K002790). In these cases, the package inserts for both the Temporary Add-on Condyle will be included with the product. The poduct of the postkage insert for the Temporay Add-on Condyle is specific in identifying that on only indicated for temporary reconstruction and is not intended to a permanent implant

Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to 16mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. The Lorenz Sternal Closure System will be marketed as non-sterile, single use devices.

The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.

This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.

Pectus Pre-bent Support Bar: A stainless steel or titanium bar, variable length from 7 to 17 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall. The bar is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient. The titanium bar is only used when the patient has a nickel allergy. Pectus Titanium Support Bar Stabilizer: A titanium elongated plate with a dovetail slot in the center of the plate for the Pectus Bar to slide into. Two lips come up over the bar to secure the Pectus Bar within the slot of the stabilizer. The stabilizers have two holes on either side of the slot to suture the stabilizer to the lateral chest wall together with the support bar preventing lateral movement and flipping of the bar.

OtoMimix™ is indicated for the following: 1. Augmentation or coupling of the middle ear ossicles. 2. Attachment of the middle ear ossicles to middle ear implants. 3. Mechanical stabilization of middle ear prostheses 4. Reconstruction of the posterior canal wall

OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.

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.

Self-Drilling Radiographic Markers are used as radiopaque markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

The Self-drilling Radiographic Markers are zirconium bone screws used as radiographic markers, and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants after surgery with the aid of an Xray. Self-drilling Radiographic Markers are applied with manual surgical instruments.

The Lorenz Self-Drilling IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.

The Self-drilling IMF bone screw for maxillomandibular fixation is 2.0mm in diameter and the thread lengths may range from 5mm - 11mm. The head has a relief groove which may or may not have a hole in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible.

Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to I the Lorental Storal Clobal v Systems so that a preditled hole is not required, but may be used.