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510(k) Data Aggregation
K Number
K203108Device Name
Ignite Stemless Anatomic Shoulder System
Manufacturer
Ignite Orthopedics LLC
Date Cleared
2021-07-16
(274 days)
Product Code
PKC, PAO
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
Ignite Orthopedics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ignite Stemless Anatomic Shoulder Prosthesis is intended for use in total shoulder replacement procedures to address the following:
- · Osteoarthritis;
- Posttraumatic arthrosis;
- · Focal avascular necrosis of the humeral head;
- · Previous surgeries of the shoulder that do not compromise the fixation.
Device Description
The Ignite Stemless Anatomic Shoulder System is total shoulder arthroplasty system consisting of stemless humeral implants (multiple sizes), offset taper adapter, humeral heads (38 - 57mm diameters), and glenoid components (multiple sizes).
The anatomic stemless humeral construct consists of an additively manufactured Ti-6A1-4V Stemless Humeral Implant, a wrought Cobalt-Chromium Humeral Head, and a wrought Ti-6Al-4V Taper Adapter. The all-poly Anatomic Glenoid consists of a Highly Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene articulation surface. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.
The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.
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K Number
K202716Device Name
Ignite Anatomic Shoulder System
Manufacturer
Ignite Orthopedics LLC
Date Cleared
2021-05-20
(245 days)
Product Code
MBF, HSD, KWS, KWT, PAO
Regulation Number
888.3670Why did this record match?
Applicant Name (Manufacturer) :
Ignite Orthopedics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures the following:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Revision where other devices or treatments have failed.
- · Correction of functional deformity.
- · Fracture of the humeral head
- · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.
Device Description
The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).
The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.
The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.
The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.
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