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The BRM Extremities NewPrim device is intended for use in: - Hallux rigidus or hallux limitus; - Painful rheumatoid arthritis; - Hallux abducto valgus associated with arthritis; - Unstable or painful joint from previous surgery

The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal. The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal. The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal. The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal. The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio. The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio. The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

The Fusion Silastic System consists of a collection of flexible toe joint prostheses, manufactured from medical grade silicone (ASTM F2042). The product family is offered in five configurations to address varying indications and patient anatomy; the Gait Implant, the Gait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

The RTS® Lesser MTP Implant is intended for use in the treatment of: - · Partial or complete dislocation of the lesser metatarsophalangeal joint - · Pain associated with either rheumatoid or osteoarthritis - · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint - · Stiffness at the lesser metatarsophalangeal joint associated with joint disease - · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.

The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials

The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of: - Hallux limitus or hallux rigidus - Painful rheumatoid arthritis - Hallux abducto valgus associated with arthritis - Unstable or painful joint from previous surgery

The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

The indications for the OrthoFlex Rod include: - Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis - Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis - Revision of a failed arthroplasty or arthrodesis

The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.

Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for: - Partial or complete dislocation of the lesser metatarsophalangeal joint - Pain Associated with rheumatoid or osteoarthritis - Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint . - Stiffness at the lesser metatarsophalangeal joint associated with joint disease - Kohler's disease - Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state

The Lesser Metatarsal Phalangeal Joint Implant is a double-stemmed silicone prosthesis, intended to supplement lesser metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the metatarsal and base of the proximal phalanx.

Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

This submission describes the OsteoMed Interphalangeal Flexible Stabilizing Rod System intended for indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; anqular deformity; impaired function and stability; pain; impaired toe length ratio. OsteoMed Interphalangeal Flexible Stabilizing Rod Implants are intended for single use only. The OsteoMed Interphalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the interphalangeal joints of the lesser toes. It is constructed of medical grade silicone elastomer. The OsteoMed Interphalangeal Flexible Stabilizing Rods are offered in diameters of 2.0mm through 2.5mm. Drills and sizers will also be a part of the system.

Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.

The OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the lesser metatarsophalangeal joints of the foot. It is constructed of medical grade silicone elastomer. The OsteoMed Metatarsophalangeal Flexible Stabilizing Rods are offered in diameters of 2.5mm through 3.0mm. Drills and sizers will also be a part of the system.

Futura Biomedical Classic Great Toe Implant is indicated for: - Hallux limitus or hallux rigidus - Painful rheumatoid arthritis - Hallux abducto valgus associated with arthritis - Unstable or painful joint from previous surgery

The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

Futura Biomedical Classic Great Toe Implant is indicated for: - Hallux limitus or hallux rigidus . - . Painful rheumatoid arthritis - Hallux abducto valgus associated with arthritis ● - Unstable or painful joint from previous surgery .

The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.