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The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following: 1. Osteoarthritis 2. Rheumatoid arthritis 3. Tumor conditions involving the upper third of the femur of the Acetabular 4. Ankylosing spondylitis 5. Psoriatic arthritis 6. Old osteomyelitis -- with a long infection-free period and a normal WBC. ESR and C-reactive protein 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head 8. Post-traumatic fracture/dislocation of the hip 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present 11. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty. These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem.

The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem. Manufactured by CeramTec AG, the Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474, with a small amount of magnesium to prevent grain growth. The Ceramic Ball Heads are available in various sizes from 28, 32 up to 36 mm, in small medium and large for each.

The PiGalileo™ Total Hip Replacement (THR) System is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. hip center, pelvic plane etc.). Examples of some surgical procedures include but are not limited to: Primary total hip replacement Revision hip surgery Minimally invasive hip arthroplasty

The PiGalileo™ Total Hip Replacement (THR) software application when provided with the PiGalileo™ system cart results in the PiGalileo™ THR System, a softwarecontrolled electromechanical stereotaxic device for computer-aided navigation of PiGalileo™ surgical instruments with the purpose of assisting the surgeon in optimally positioning hip prostheses. Refer to Section 11.0 for an in depth description of the PiGalileo™ THR System. The PiGalileo™ THR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively. The PiGalileo™ THR System is based on common stereotaxic technology in which Infrared (IF) LED (light emitting diodes) or passive markers on the surgical instruments allow the instruments to be tracked in real time in the surgical field. In the case of PiGalileo™ THR System, patient data that is required to navigate the surgical instruments is collected during the procedure. The system utilizes this data to establish a connection between passive locaters, i.e., Infrared (IF) light, and the system's IF camera as previously described tracks the surgical instruments in real time in the surgical field. The precision of navigation-assisted surgery depends on accurate scanning of skeletal landmarks. Scanned morphological data represents the basis for calculating the position of the hip cup and hip stem. Scanned points must represent unique anatomic landmarks so that they can be located in a safe and reproducible manner throughout surgery. For cup navigation, the spinae, left/ right are scanned as well as the symphysis. Each point is scanned three times to enhance precision and used for inclination and anteversion alignment. For stem navigation, the sagital plane is determined from the tibialis anterior and the intersection point on the femur. The position and alignment of the proximal stem axis are determined with a probe which provides the basis of the varus/valgus alignment. The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times. Risk mitigations implemented under Design Controls ensure that sufficient fail safe mechanisms allow the surgeon to convert to non-navigated conventional surgical techniques at any time. The navigation platform for the PiGalileo™ THR System is the same as the navigation platform cleared under PiGalileo™ TKR System, K061362, and includes the following elements: (a) System Cart housing the following items; there are no changes to the system cart as compared to K061362. 1 System electronics such as CPU and connection box Monitor User Interface consisting of keyboard, touch pad and hard controls, e.g., "ON / OFF", footswitch Infrared (IF) Camera and Camera Stand/Tripod Optional printer System cabling (b) PiGalileo™ THR Software refers to the PiGalileo™ System Software and the THR software application: PiGalileo™ System Software: this software is the same as that of the PiGalileo™ TKR System; there are no changes to either the system software or the calculations or the landmark technique as compared to K061362. PiGalileo™ THR software application consists of two applets, PiGalileo™ Hip Cup and PiGalileo™ Hip Stem. Each applet consists of a collection of software modules that support the surgeon in hip cup and hip stem replacement. Each module is designed specifically for an implant in which the software calculates the values provided on screen differently for each implant, the specific implant geometry and the implant specific instruments. (c) Surgical Instruments: include universal instruments such as hemispheres, and various locators; navigated instruments are equipped with markers that are tracked by the stereotaxic camera. The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.

The POLARCUP® Dual Mobility System is indicated for: - All forms of osteoarthritis . - Dislocation risks . - Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint - . Femoral head necrosis - Proximal femoral fractures (especially femoral neck) . - . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component. Shell Component: The POLARCUP® shell, is manufactured from stainless steel INOX M30NW according to ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel, and is available in three configurations: - Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, with pegs and two flanges, uncemented use: allows for implantation with no pegs and no flanges, with no pegs and contoured flanges, screws in flanges but with no pegs, and two impacted pegs and two screws in flanges - . Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, without pegs and flanges, uncemented use) - . Stainless steel, mirror polished, without pegs and flanges, cemented use Note: the pure Titanium coating found in the uncemented versions is a Titanium alloy according to ISO 5832-2:1999. Implants for Surgery -Metallic Materials - Part 2: Unalloyed Titanium. The POLARCUP® shell is available in 13 sizes for each of the titaniumcoated versions for uncemented use, ranging in diameter from 43 mm to 67 mm. The mirror-polished version for cemented use is available in 11 sizes, ranging in diameter from 43 mm to 63 mm. Cortical Screws and Impacted Pegs: Cortical screws and impacted pegs, both made of stainless steel INOX 316LVM according to ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel, are available for use with the POLARCUP® shell version with pegs and flanges for uncemented use. The cortical screws are 4.5 mm in diameter and available in 6 different lengths ranging from 40 mm to 60 mm. The impacted pegs are available in a single length of 13 mm. Liner Component: The POLARCUP® liner component is a polyethylene insert, specifically Ultra-High Molecular Weight Polyethylene (UHMW PE) according to ISO 5834-2:1998, Implants for Surgery -- Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms, that retains the femoral head and moves freely in the POLARCUP® shell, allowing increased mobility and stability. The liner component is available in two internal joint diameters. 22 mm and 28 mm. The 22 mm diameter liner is available in 13 different sizes of spherical external radius of curvature whereas the 28 mm diameter liner is available in 11 different sizes of spherical external radius of curvature (to ensure a minimal thickness of 6.5 mm according to EN 12563). The POLARCUP® Dual Mobility System may be used with the following components provided that they are legally marketed in the US and meet these specifications: - Ball Heads: made of CoCrMo, ceramic or stainless steel, with diameters . of 22 or 28 mm - Femoral Stems: polished or electro-polished necks .

The PROMOS Modular Shoulder System is indicated for: - Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or inflammatory arthritis - Avascular necrosis of the humeral head - Complex fractures of the proximal humerus - Functional impairment especially in the case of post-traumatic loss of the joint configuration The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.

The modified PROMOS® Modular Shoulder System is intended to aid in the restoration of shoulder motion and elimination of pain. This device consists of two primary components, the glenoid component and the modular humeral component. The changes to the PROMOS® Shoulder that resulted in the modified PROMOS® Shoulder and are subject of this 510(k) include: - Addition of size 3.5 humeral stem, cementless . - Addition of six humeral ball heads R21 R26, with 4 mm eccentricity . - Redesign of body and inclination set to add face gear to area between . inclination set and body - Addition of three Monoblock stems, cementless, size 02/30, 35 and 40 mm . - Various labeling changes . The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe) according to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms. The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components. The modular humeral component consists of a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross-sectional shape, previously available in seven cemented and seven cementless sizes, and now available in seven cemented and eight cementless sizes. It is attached to the body via a Morse type taper. The cementless and cemented stems are fabricated from titanium alloy (Ti6Al4V) according to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. The body is made of same titanium alloy as the distal stems and is available in three sizes. The body and inclination set have been redesigned to add a face gear to the area between the inclination set and body. As before the modified inclination set consists of three components: an inclination insert, an offset module, and a ball head screw. The modular humeral heads are manufactured from wrought cobalt-chromiummolybdenum (CoCrMo) alloy according to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy, previously available in eight different sizes/eccentricities, and now available in 14 different sizes/eccentricities. Since cementless or cemented stems in size 01 may be too large for some patients, the company has developed a humeral stem, size 02. The narrow crosssection of a size 02 stem precluded a modular design, i.e., 02 size stem and a selection of bodies. As a result, the company implemented the size 02 as a Monoblock system with three different heights for body sizes 30mm, 35mm, and 40mm. The design of the cross-section is the same as mentioned above in the description of the distal stem and the stem is made of the same titanium allov. The proximal portion has also been redesigned to add face gear to the area between inclination set and body.

The PiGalileo™ TKR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g., ligament tension, limb alignment, etc.). Examples of some surgical procedures include but are not limited to: - Total knee replacement supporting both bone referencing and ligament balancing techniques - Minimally invasive total knee replacement

The PiGalileo™ Navigation (NAV) Total Knee Replacement (TKR) Computer Assisted Surgical (CAS) System (PiGalileo™ TKR System) is a softwarecontrolled electromechanical sterotaxic device for computer-aided navigation of PI Galileo surgical instruments with the purpose of assisting the surgeon in optimally positioning prostheses of the TC-PLUS and VKS knee systems. The PiGalileo™ TKR System is based on common stereotaxic technology in which Infrared (IF) LED (light emitting diodes) or passive markers on the surgical instruments allow the instruments to be tracked in real time in the surgical field. In the case of PiGalileo™ TKR System, patient data that is required to navigate the surgical instruments is collected during the procedure. The system utilizes this data to establish a connection between passive locaters, i.e., Infrared (IF) light, and the system's IF camera as previously described tracks the surgical instruments in real time in the surgical field. Two passive locators are attached to the tibia and distal femur during surgery, where one locater is mobile to determine specific landmarks, known as Bone Referencing (BR) on the tibia and femur. Once the system has collected the information, the system positions a motorized cutting guide on the femur to support the surgeon during surgery and provides information to position or "navigate" additional instruments. The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times. Positions of the motorized cutting guide may also be adjusted manually. Risk mitigations were implemented under Design Controls to ensure that sufficient fail safe mechanisms allow the surgeon to convert to non-navigated conventional surgical techniques at any time. The PiGalileo™ TKR System consists of three main elements: - System Cart which houses: - System electronics and cabling - Monitor - User Interface - IF Camera and Camera Stand - Optional printer - Software: - PiGalileo System Software - Application Software - a) PiGalileo TKR BR - b) PiGalileo TKR Ligament Balancing (LB) - c) PiGalileo TKR Light - d) PiGalileo TKR Minimally Invasive Surgery (MIS) - Standard Surgical Instruments and application-specific surgical instruments

The PROMOS® Shoulder is indicated for: - Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis - Fracture or avascular necrosis of the humeral head - Post-traumatic loss of joint configuration, especially in the case of functional impairment - Humerus fracture The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement only.

The PROMOS® Shoulder will help in restoring shoulder motion and eliminating pain. The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe). The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components. The humeral component is modular with a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross sectional shape and available in seven cementless sizes. It is attached to the body via a Morse type taper. Both cemented and cementless stems are fabricated from titanium alloy (Ti6Al4V) that conforms to ISO 5832-3. The body is made of titanium alloy and is available in three sizes. The body has a cavity in the proximal portion to accept the inclination set. The inclination set consists of an insert, offset module and ball screw. The ball screw inserts through the offset module and insert, and the assembly is threaded into the cavity in the body. The offset module can be set at various positions and when the ball screw is tightened into the body the offset module is locked into place. The offset module has a male Morse type taper to which the humeral head is attached. All components of the inclination set are made from titanium alloy. The offset module is available in three different heights resulting in the humeral head being placed at three heights. The modular humeral heads are manufactured from CoCrMo alloy that conforms to ISO 5832-12. The head is available in eight different sizes.

The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in: - Pertrochanteric femoral fractures . - Subtrochanteric femoral fractures and . - Lateral femoral neck fractures . Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

The SLIM Gliding Nail Systems designed for internal fixation in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. The system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.

The Modular PLUS Revision Stem is a cementless two part modular stem that consists of distal anchorage module and proximal revision module, connected by a multi-stage tapered coupling, secured by a cylindrical screw. The proximal module has a standard 12/14 taper to accept modular heads. The Modular PLUS stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um. This submission adds three additional proximal modules, designated as size AX, BX and CX, have the same circumferential dimensions as the previously cleared AS/AL, BS/BL and CS/CL proximal modules. The differences lie in the overall length of the components. The AX module increases by 15.4mm, the BX module by 18.7mm and the CX module by 22.7mm.

The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.

The IP-XS Compression Nail system is for bones with small comes in diameters of 3.5mm and 4.5mm. They have a circular cross section with multiple transverse holes for interlocking components. The two proximal transverse holes are elongated to allow the interlocking component to move axially and apply compression to the bone fragments. The proximal end has an internal axial threaded hole to receive a compression screw. Threaded Kirschner wires 02.0mm and 01.6mm are used as the interlocking components.

VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision k nee a rthroplasty w here the collateral ligaments a re intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, or connective tissue disorders. It is for cemented use only.

The VKS/TC-PLUS Revision Knee is a tri-compartmental knee consisting of a femoral component, tibial baseplate, tibial insert, femoral and tibial augmentation blocks and intramedullary stems. The VKS/TC-PLUS Revision femoral component is available in five size and right and left configurations. It has a post in the box into which is machined a female Morse type taper to receive an intramedullary stem. It is also configured to received posterior and distal augmentation blocks. The VKS/TC-PLUS Revision tibial baseplate has five sizes, right and left, and has the same outer profile as the VKS baseplates cleared in K022204. The tibial insert locking mechanism is the VKS Knee. The inferior surface of the baseplate has a short post with a female type taper machined into it to receive modular stems and a hole through the baseplate to receive a screw to augment the baseplate/stem connection. The stems are as used on the femoral component. The inferior surface of the baseplate also has two fins that extend posterior/laterally from the post. The same ultra-congruent insert cleared with the VKS Knee under K022204 is used with the VKS/TC-PLUS Revision Knee. The femoral augmentation blocks are available in distal and posterior configurations, 5mm and 10mm thickness. The tibial augmentation blocks are available in half blocks so that medial, lateral or full augmentation can be achieved. They are also available in 5mm and 10mm thickness.