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The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.

The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation. The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients. Cranium - . The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, and infants. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs as detailed in the table below.

Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.

The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 40 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.

The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.

The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation. The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors. The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.

The OsteoMed Cranial Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed Cranial Distraction System implants are intended for single use only.

The OsteoMed Cranial Distraction System is comprised of distractors, spacers, screws and instrumentation. The distractor is an internal distraction device for bone elongation of cranial bones. The distractor is anchored between the osteotomy with 1.2mm standard or 1.2mm AutoDrive screws previously cleared under K924138 and K023260, respectively. The distractor is activated using a distractor tool via the distraction rod. The distraction rod is preassembled within the distractor device. The non-threaded portion of the distractor rod can be removed during the consolidation period. The distractors, spacers, and screws are removed after consolidation. The instruments include distractor tool, drills, plate bending forceps, plate cutters and screwdrivers to facilitate the placement of screws and modification of the distractor assembly plates. A distractor rod removal tool is also available to partially remove the distractor rod leaving the distracted device in place. The distractor assembly is made from Titanium (ASTM F-67) and Titanium Allov (ASTM F-136), and the spacer is made from Titanium (ASTM F-67). The screws are made from Titanium Alloy (ASTM F-136). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.