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510(k) Data Aggregation
K Number
K171703Device Name
PUMA System
Manufacturer
Date Cleared
2018-03-01
(266 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Panther Orthopedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PUMA System is intended as an adjunct in fracture repair involving metaphyseal, and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The PUMA System when used for fixation of bone-to-bone or soft tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the PUMA System is indicated to provide fixation during the healing process for the following:
- . Fixation of Syndesmosis disruptions in connection with Weber B and C ankle fractures.
- Fixation of Syndesmosis disruptions in connection with dorsal distal radioulnar ligament (DRUL) disruptions.
- Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc Injury.
- Hallux Valgus reconstruction by providing for the reduction of 1st and 2nd metatarsal intermetatarsal angle.
Device Description
The PUMA System comprises three components: one suture (PUMA Body) made of a nickel titanium alloy (nitinol), and two anchors (PUMA Anchors) made of polyether-ether-ketone (PEEK). The PUMA Body is inserted through bones or soft tissues that need to be stabilized. Once placed, the device secures the bone and/or tissue by means of the PUMA Anchors affixed to each side of the Body. The elastic/superelastic shape characteristic of the nitinol confers some flexibility while maintaining the stability of the PUMA System.
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