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Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Inion Spinal Graft Containment System includes plates, meshes and screws which are made of degradable polylactic acid copolymers, P(L/DL)LA. Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The plates and screws include tantalum spheres for postoperative radiographic imaging. The implants are offered in different shapes and sizes suitable for this application. Inion Spinal Graft Containment System implants are provided sterile to the user and are noncollagenous. The shelf life of the device is 3 years.

A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures. B. Specific indications: 1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible 2. Metacarpus, proximal and middle phalangeal bones 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Inion CPS/OTPS FreedomPlate™ implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers and they are provided in sizes typical to this application. Inion CPS/OTPS FreedomPlate 1.5 implants gradually lose their strength during 18-36 weeks in vivo. Bioresorption takes place within two to four years. Inion CPS/OTPS FreedomPlate™ implants are provided sterile to the user. The shelf life of the device is 3 years.

A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM issuplants are generally intended for maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization. B. Specific indications: - Fractures and osteotomies of the malleoli - Ankle fractures

The modified Inion OTPS™ Biodegradable Fixation system implants are identical to the currently cleared devices except for the modifications which have been detailed in section 3 of this submission. Inion OTPS™ Biodegradable Fixation System implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers. Inion O'EPS™ Biodegradable Fixation System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissuc grafts.

Inion Hexalon™ Biodegradable ACL/PCL screws are intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts. The new screws are identical with the other implants in the previously 510(k) cleared Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280) in terms of copolymer composition, colour additive, intended use and indications for use as described in the device labelling. manufacturing method and sterilization method.

The INION S-1™ BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.

Inion S-1™ Biodegradable Anterior Cervical Fusion System, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion rigit fixances (10), posterinain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications. Inion S-1 ™ Biodegradable Anterior Cervical Fusion System consist of cervical spinal fusion plates and screws, and is made of resorbable polylactic acid copolymers, P(L/DL)LA 80:20. Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years. Inion S-1 ™ Biodegradable Anterior Cervical Fusion System is provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

The INION OTPS™ BIODEGRADABLE DISTAL RADIUS PLATE implants are indicated for use in open reduction and internal fixation of fractures, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization.

Inion OTPS™ Biodegradable Distal Radius Plate implants are indicated for use in open reduction and internal fixation of fractures, osteotomies, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization. Inion OTPS 100 Biodegradable Distal Radius Plate implants are made of is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in sizes typical to this application. Inion OTPS™ Biodegradable Distal Radius Plate implants gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years. Inion OTPS™ Biodegradable Distal Radius Plate implants are provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. Specific indications: Fractures of the cranium, mid-face and maxilla; Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations); LeFort (I, II, III) osteotomies; Pediatric reconstructive procedures; Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla; Craniotomy flap fixation.

The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. Specific indications: Fractures of the cranium, mid-face and maxilla; Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations); LeFort (I, II, III) osteotomies; Pediatric reconstructive procedures; Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla; Craniotomy flap fixation. The new large X plate is identical with the other implants in the previously 510(k) cleared Inion CPSTM Baby 1.5 Bioabsorbable Fixation System (K010351) in terms of copolymer composition, intended use and indications for use as described in the device labelling, manufacturing method, sterilization method and packaging solution.

- General indications: The INION CPSTM BABY 1.5 BIOABSORBABLE FIXATION A. SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. - B. Specific indications: - · Fractures of the cranium, mid-face and maxilla - · Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations) - · LeFort (1, II, III) osteotomies - · Pediatric reconstructive procedures - · Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla - · Craniotomy flap fixation

The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. The new 40-hole plate and 64-hole plate are identical with the other implants in the previously 510(k) cleared Inion CPS™ Baby 1.5 Bioabsorbable Fixation System (K010351) in terms of copolymer composition, intended use and indications for use as described in the device labelling, manufacturing method, sterilization method and packaging solution.

The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation The missi OFF . Breedomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). Previously 510(k) cleared Inion OTPS™ Biodegradable Pin (K031712) is manufactured by extrusion followed by grinding and cutting. With this special 510(k) we inform for additional manufacturing method by injection moulding followed by cutting. Injection moulded Inion OTPSTM Biodegradable Pins are identical in all the other aspects with the predicate pins except this manufacturing method. Material recipe with copolymer composition is identical. Only difference is that the molecular weight is slightly higher with the extrusion recipe than with the injection moulding recipe.

These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

Screws are generally intended for alignment and fixation of bone fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or brace). The Inion OTPS™ Screws are offered in several dimensions and lengths typical for this application. The Inion OTPS™ Screws are made of resorbable polylactic acid / trimethylenecarbonate [poly(L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. The Inion OTPS™ Screw gradually loses its strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.