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510(k) Data Aggregation
(235 days)
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(259 days)
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(234 days)
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(25 days)
The prostheses from FH Industrie are designed for specific indications such as:
Simple humeral prosthesis
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
Total anatomical prosthesis (cemented glenoid implant with pegs)
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Post-traumatic sequela, functional rotator cuff with glenoid injury.
TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)
- Centred glenohumeral osteoarthritis
- Rheumatoid polyarthritis
- Post-traumatic sequela with glenoid injury
- Revision for glenoid loosening
- Glenoid bone loss, where bone graft is needed
A functional rotator cuff is necessary to use this device
REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.
At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation. Metaphyseal stems and diaphyseal stems are intended for use without cement. The glenoid bases (metal-back or porous) are intended for cementless use with the addition of cortical and cancellous bone screws.
The JARVIS Metaphyseal Stem is modification to the metaphysis component of the Arrow Short Stem prosthesis (K202024). The Metaphyseal Stem is intended to be used with the diaphyseal component of the modular ARROW Short Stem device (K202024), including the JARVIS Diaphyseal Stem Standard (K253345). The subject modifications include optimized leading edges as well as the inclusion of suture holes for soft tissue reattachment. The JARVIS Metaphyseal Stem is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 with a pure titanium plasma spray coating per ASTM F1580.
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(255 days)
The 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
When used with the specified treatment protocol, it is also intended for histological clearance of biopsy-confirmed nodular or superficial basal cell carcinoma (BCC) located on the trunk, in individuals with Fitzpatrick skin types I-II. The rate of recurrence after this procedure is not known.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The 1064 Laser System and Accessories are indicated for use on all skin types (Fitzpatrick I-Vl), including tanned skin.
The 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
The JOULE 1064nm Laser System is a device which delivers laser energy at a wavelength of 1064 nm. It consists of a console and laser delivery accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system with a treatment handpiece. The user activates laser emission by means of a footswitch.
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(450 days)
Jason membrane alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration.
- in case of surgical bone defects and bone wall defects
- in the context of sinus floor augmentation and for support of the Schneiderian membrane
- in the context of maxillary ridge augmentation
- in the context of maxillary ridge reconstruction for prosthetic treatment
- in the context of a treatment of fenestration defects
- in case of periodontal bone defects (one to three-wall defects, class I and II furcation defects)
- in case of dehiscence defects
- after apicoectomy, cystectomy, resection of retained teeth and resection of other bone lesions
- in extraction sockets after tooth extractions
- in case of immediate or delayed augmentation around implants in extraction sockets
Jason® membrane is a completely resorbable collagen membrane used in maxillofacial surgery, implantology, periodontology, oral surgery and endodontology as a barrier membrane to support guided tissue regeneration (GTR) and guided bone regeneration (GBR), for covering implants and for periodontal tissue regeneration. Jason® membrane is produced from porcine pericardium in a standardized, controlled purification process. When dry Jason® membrane is a white collagen matrix with a very dense fiber structure. It possesses sufficient rigidity and stability for a broad variety of intended uses. Jason® membrane possesses a physiological neutral pH-value. Jason® membrane typically resorbs within 12 weeks after implantation. The Jason® membrane is intended to be used in adults only.
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(29 days)
The prostheses from FH Industrie are designed for specific indications such as:
SIMPLE HUMERAL PROSTHESIS
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH PEGS)
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Post-traumatic sequela, functional rotator cuff with glenoid injury.
TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)
- Centred glenohumeral osteoarthritis
- Rheumatoid polyarthritis
- Post-traumatic sequela with glenoid injury
- Revision for glenoid loosening
- Glenoid bone loss, where bone graft is needed
A functional rotator cuff is necessary to use this device
REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.
For all types of prosthesis, the glenoid baseplate (porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use.
At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.
The JARVIS Diaphyseal Stem Standard is an extension of humeral stem range of the Arrow prosthesis. The JARVIS Diaphyseal Stem Standard is intended to be used with the Metaphyseal component of the modular ARROW Short Stem device (K202024). The JARVIS Diaphyseal Stem Standard is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3.
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(263 days)
JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.
The JOVS Electric Stimulation Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It mainly consists of main unit, charging and disinfection base, and power cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging. The device is only home environment use, which has the spring electrode head (electric stimulation) to provide the following function:
The JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.
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(110 days)
Jmoon FlexGlow Light Therapy Device is an over the counter device that is intended:
- the Red light and Infrared light is indicated for use in the treatment of full face wrinkles,
- the Blue light and Red light indicated for the treatment of mild to moderate inflammatory acne.
Jmoon FlexGlow Light Therapy Device is an exclusive mirrored tabletop device that contains 464 LEDs. It utilizes LED(light-emitting diode) technology to emit energy in the blue, red and near-infrared spectra for the aim to improve the skin appearance, helping to reduce wrinkles, like fine lines and crow's feet, and treat mild to moderate inflammatory acne. The specific wavelengths of light can act on different skin layers to produce different photobiological effects. The device is to be used at 1 cm distance.The flexible and foldable device unit is designed to be placed on a table for easy exposure to the face and body to ensure consistent light treatment. There are three modes: Acne defense Mode(M01), Anti-wrinkle recovery Mode(M02) and Dual care Mode(M03).
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(164 days)
JDEvolution Plus L and JDEvolution Plus LE implant system is intended for surgical placement in the upper jaw.
JDEvolution Plus L and JDEvolution Plus LE implant system provides a means for prosthetic attachment in partially or fully edentulous spans with multiple teeth utilizing delayed, or immediate loading, or as a terminal or intermediary abutment for fixed ore removable bridgework or to retain overdentures. JDEvolution Plus L and JDEvolution Plus LE is intended for immediate function multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
JDEvolution Plus L and JDEvolution Plus LE implants with lengths of 18, 20, 22, 24, 26 mm are only indicated for multiple unit restorations in splinted applications with at least two implants when placed in the maxilla.
JDEvolution Plus L and LE, are tissue level implantable devices produced in commercially pure titanium, intended for surgical placement in the upper jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
JDEvolution Plus L and LE are endosseous dental implants intended for surgical placement in the upper jaw. JDEvolution Plus L and LE implants includes dental implant fixtures only.
JDEvolution Plus L and LE provide a means for prosthetic attachment partially or fully edentulous spans with multiple teeth utilizing delayed or immediate loading when good primary stability is achieved in order to restore patient chewing function.
The subject implant bodies are compatible with abutments cleared in K143142 and K233896
Knowledgeable clinicians are in charge for the following of a delayed instead immediate loading, evaluating the stability of the implant sites after the surgical operation.
The device insertion occurs at the end of the surgical procedure which consists in an osteotomy of the upper jaw.
JDEvolution Plus L and LE implants are single use devices, supplied sterile and that cannot be re-cleaned or re-sterilised.
JDEvolution Plus L and LE Implant System is a two-piece implant made of commercially pure titanium.
The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.
The connection is done through an internal hexagon: abutments and other accessories are exclusively designed for JDEvolution Plus L and LE Implant System.
Endosseous dental implant and abutment will represent the support, for the dentist, for building the artificial replacement tooth.
The artificial replacement tooth component is not part of this submission.
The main features of JDEvolution Plus L and LE Implant System are summarized in the table below:
JDEvolution Plus:
Materials: Titanium grade 4 (diameter 4.0)
Design:
General Features: Endosseous implant with connection with internal hexagon
Shape:
Collar: Machined gingival collar of 1,5mm length for all the lengths
Body: Double thread with 0.6 mm lead: straight cylindrical of 4,0 mm diameter for a total length (including collar) of 20 / 22 / 24 / 26mm. Tapered apex with bone cutting flutes.
Double thread with 1.2 mm lead: tapered body of 4,0 mm for a total length (including collar) of 18 / 20 / 22 / 24 / 26mm
Thread: Double thread with 0.6 mm or 1.2 mm lead
Abutment: To be connected with the Conical abutment cleared under K143142, K233896
Ti gr.5: Straight– angled 15° - angled 17° - angled 25°- angled 30°
Surface:
Collar: Machined, without any surface treatment
Body: Treated through sandblasting followed by acid etching (SLA) for the full length of the endosseous portion for all variants (the surface treatment is the same of the JDentalCare Implant System JDIcon cleared under K 182081)
Thread:
Body: Double thread
outline: trapezoidal
Thread lead: 0.6 mm (for tapered body version)
Thread lead: 1.2 mm (for straight cylindrical body version)
Self-Threading Capacity: Self-threading capacity in both direction
Dimensions:
Mean Diameter: 4.0 mm
Total Length: 18mm (only for JD Evolution Plus LE Implant), 20mm, 22mm, 24mm and 26mm
Implanted Length: 16.5mm (only for JD Evolution Plus LE Implant), 18.5mm, 20.5mm, 22.5mm and 24.5mm
Connection:
Shape: Internal hexagonal connection (Hexagon dimension of 2.425 mm)
Packaging:
Type of package: Blister with internal vial and protective cap for implants
External carton box as commercial packaging
Blister material: Tyvek
Polyester PET MO65
Vial material: Polystyrene Empera 116 vial closed with Eralyte PET cap
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