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510(k) Data Aggregation
K Number
K221220Device Name
Montross Extremity Medical Hemi Implant System
Manufacturer
Montross Extremity Medical
Date Cleared
2023-04-19
(357 days)
Product Code
KWD
Regulation Number
888.3730Why did this record match?
Applicant Name (Manufacturer) :
Montross Extremity Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock.
Indications include:
- Hallux valgus or Hallux limitus
- Hallux rigidus
- Unstable or painful metatarsallphalangeal (MTP) joint
Device Description
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component (four sizes for each component) designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. The implants are made from Cobalt Chrome per ASTM F-1537.
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