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510(k) Data Aggregation
K Number
K132496Device Name
ARTHROSURFACE TOEMOTION
Manufacturer
ARTHROSURFACE, INC.
Date Cleared
2014-02-26
(201 days)
Product Code
LZJ
Regulation Number
N/AWhy did this record match?
Product Code :
LZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only.
Indications for use include:
- Painful degenerative metatarso-phalangeal joint change .
- . Hallus rigidus stage 3 and 4
- . Hallux valgus and hallux rigidus
- Hallux limitus with painful arthrofibrosis .
- Revisions after moderate proximal phalanx resection .
Device Description
The Arthrosurface® Total Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 15 metatarsal head and the base of the proximal phalanx. These two implants replace the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex.
The Metatarsal Implant incorporates a CoCrMo articular resurfacing component per ASTM F799 with CP Ti Plasma Spray coating per ASTM F1580 and a Ti-6AI-4V ELI alloy fixation component per ASTM F136 that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. The device is 15mm articular implant with a dorsal flange feature for additional implant coverage in the dorsal plane.
The Proximal Phalanx Implant consists of a Ti-6Al-4V ELI alloy fixation component per ASTM F136 with CP Ti Plasma Spray coating per ASTM F1580 and an Ultra High Molecular Weight Polyethylene inlay per ASTM F648.
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K Number
K102549Device Name
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2010-12-21
(105 days)
Product Code
LZJ
Regulation Number
N/AWhy did this record match?
Product Code :
LZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:
- Painful degenerative metatarso-phalangeal joint change .
- Hallux rigidus stage 3 and 4 ◆
- Hallux valgus and hallux rigidus .
- Hallux limitus with painful arthrofibrosis .
- Revisions after moderate proximal phalanx resection .
Device Description
The Ascension® MOVEMENT Great Toe System, Total Arthroplasty device is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device couples with the Ascension metatarsal hemi-arthroplasty device to allow total arthroplasty of the 1st MTP joint. The device is designed for cemented fixation. The device is boxed individually and delivered sterile for single use. The device incorporates four anatomically designed base geometries with appropriately sized stems. The stem is cylindrical with tapered ribs to provide rotational as well as axial stability of the seated implant. System instrumentation is designed to offer precise implant preparation.
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K Number
K072251Device Name
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
Manufacturer
MERETE MEDICAL GMBH
Date Cleared
2008-05-08
(269 days)
Product Code
LZJ
Regulation Number
N/AWhy did this record match?
Product Code :
LZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint. The device is intended for cemented use only. Indications for use include:
- Painful degenerative metatarso-phalangeal joint change
- Hallux rigidus stage 3 and 4
- Hallux valgus and hallux rigidus
- Hallux limitus with painful arthrofibrosis
- Revisions- after moderate proximal phalanx resection
Device Description
The Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece prosthesis that replaces the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex.
The prosthesis consists of an anatomically shaped and polished metatarsal implant, made of CoCrMo, which glides on a polyethylene inlay that is preassembled on a conically shaped phalangeal component made of titanium alloy Ti-6AI-4V.
Metatarsal and Phalangeal implant are intended for cemented use only.
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