Search Results
Found 8 results
510(k) Data Aggregation
K Number
K212297Device Name
Omni Foot and Ankle Plating System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2021-08-20
(29 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Extremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omni Foot and Ankle Plating System is intended for use in internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
Device Description
The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.
Ask a Question
K Number
K211261Device Name
Axis Charcot Fixation System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2021-05-28
(32 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Extremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
Device Description
The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction. The modified device adds additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes offer the surgeon options for placement based on patient anatomy.
Ask a Question
K Number
K201556Device Name
Intraosseous Fixation System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2020-07-08
(28 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Extremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intraosseous Fixation System is intended for reduction of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device.
Device Description
The Extremity Medical Intraosseous Fixation System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunion of the small bones and joints of the hand, wrist, foot, and ankle. The system consists of solid and cannulated screws, with the option of adding Washers; a standard/flat Washer, a Washer Post (referred to as an X-Post) for engaging the head of the Screw, and an X-Clip for engaging the threads of the screw. The X-Post/X-Clip come in varying sizes and lengths. Similarly, the lag screws come in varying diameters and lengths, and are also available in short and long thread configurations. The modified device is a product line extension and improvement to the Screw and Washer System, cleared under K121349, intended to provide modularity to the end user. New components to the system consist of cannulated 3.5 mm screws and implant accessories, X-Posts and X-Clips, to offer surgeons options for placement. Additionally, the system will offer additional thread length options for the 4.5mm screws cleared under K121349 and 6.5mm screws substantially equivalent to those cleared under K121349.
Ask a Question
K Number
K191525Device Name
KinematX Total Wrist Arthroplasty System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2020-03-04
(268 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Applicant Name (Manufacturer) :
Extremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:
1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
2. Revision where other devices or treatments have failed
3. Scapholunate Advanced Collapse (SLAC)
4. Rheumatoid Arthritis
The device is intended to be implanted with bone cement.
Device Description
The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components:
1) Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
2) Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.
Ask a Question
K Number
K192592Device Name
Axis Plating System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2019-11-21
(62 days)
Product Code
HRS, HTN, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Extremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axis Plating System is indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathy (Charcot).
Device Description
The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti-6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by geometry and number of holes. The plate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to 50mm. The System offers 4.0mm cannulated screws and beams in various lengths to be used as adjunctive fixation. The 4.0mm cannulated screws and beams can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.
Ask a Question
K Number
K172260Device Name
Omni Foot Plating System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2017-11-06
(102 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Extremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.
Device Description
The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Peg") which contains a locking feature at the distal end for compression/stabilization.
Ask a Question
K Number
K171018Device Name
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2017-07-13
(99 days)
Product Code
HWC, HTN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Extremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Axis Charcot Fixation System:
The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthopathy (Charcot).
4.5 to 8.5 Screw System:
The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.
Device Description
Axis Charcot Fixation System
The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction.
4.5 to 8.5 Screw System
The 4.5 to 8.5 diameter screws consists of cannulated, titanium alloy fixation screws for use in bone reconstruction, osteotomy, arthrodesis and fracture repair and fixation in the foot.
Ask a Question
K Number
K133636Device Name
EXTREMITY MEDICAL HAMMERTOE DEVICE
Manufacturer
EXTREMITY MEDICAL, LLC.
Date Cleared
2014-03-28
(122 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EXTREMITY MEDICAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Device Description
The HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK implant and a set of instruments used for implant site preparation and delivery. The device is offered in small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.
Ask a Question
Page 1 of 1