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510(k) Data Aggregation
K Number
K123926Device Name
METASURG NITINOL STAPLE IMPLANT
Manufacturer
METASURG
Date Cleared
2013-05-03
(134 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
METASURG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metasurg Nitinol Staple implant is indicated for fixation and arthrodesis of the associated bones and joints of the hands and feet.
The Metasurg Nitinol Staple implants are intended for single use only.
Device Description
The Metasurg Nitinol Staple Implant is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
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K Number
K111265Device Name
METASURG SUBTALAR IMPLANT
Manufacturer
METASURG
Date Cleared
2011-08-09
(97 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
METASURG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications include:
- Severe pronation .
- Calcaneal valgus deformity .
- Plantarflexed talus .
- Failed correction with long term orthotic treatment .
- Congenital and painful flatfoot deformity .
- . Repair of tarsal coalitions
- Subtalar instability .
- Posterior tibial tendon dysfunction .
- Paralytic flat foot deformity .
The Metasurg subtalar implants are intended for single use only.
Device Description
The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The implant is used in the treatment of the talus relative to the calcaneus.
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K Number
K111536Device Name
METASURG DIGIFUSE IMPLANT
Manufacturer
METASURG
Date Cleared
2011-07-21
(49 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
METASURG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
- Hammer toe deformity
- Claw toe deformity
- Mallet toe deformity
- Other deformities of the feet and hands
The Metasurg DigiFuse implants are intended for single use only.
Device Description
The Metasurg DigiFuse Implant is a one-piece threaded device made of titanium intended to be implanted into the medullary bone of the lesser digits. The implant is offered in 4 variations consisting of the combination of 2.0mm and 2.5mm threads and 0° and 10° blades.
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K Number
K083469Device Name
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
Manufacturer
METASURG
Date Cleared
2009-02-13
(81 days)
Product Code
KWD
Regulation Number
888.3730Why did this record match?
Applicant Name (Manufacturer) :
METASURG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.
The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.
The MetaSurg cannulated titanium hemi implant is intended for single use only.
Device Description
The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.
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K Number
K070441Device Name
METASURG SUBTALAR IMPLANT
Manufacturer
METASURG
Date Cleared
2007-05-08
(82 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
METASURG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
The Metasurg subtalar implants are intended for single use only.
Device Description
The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 6 sizes ranging from 7mm - 12mm in diameter. The implant is used in the treatment of excessive motion of the talus relative to the calcaneus.
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