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510(k) Data Aggregation
K Number
K203779Device Name
Symmetric Total Knee System
Manufacturer
Signal Medical Corporation
Date Cleared
2021-06-10
(164 days)
Product Code
MBH, JWH
Regulation Number
888.3565Why did this record match?
Applicant Name (Manufacturer) :
Signal Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Symmetric(TM) Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:
1. Rheumatoid arthritis,
2. Post-traumatic arthritis,
3. Osteoarthritis,
4. Degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
5. Failed osteotomies, unicompartmental replacement, or total knee replacement.
All components are for cemented use only.
Device Description
The Femoral components are cobalt chromium alloy (ASTM F75). Tibial articular inserts and patellar components are UHMWPE (ASTM F648). Tibial trays, metaphyseal and revision stems, femoral and tibial wedges and cones, and screws (K961157), are titanium (ASTM F1472). Coated cobalt chromium and titanium components feature a coating of plasma sprayed titanium (ASTM F1580).
The purpose of this 510(k) is to submit an additional sterilization method of a flexible bag system. Other descriptive details remain unchanged from the predicate.
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K Number
K080199Device Name
SYMMETRIC TOTAL KNEE SYSTEM
Manufacturer
SIGNAL MEDICAL CORPORATION
Date Cleared
2008-07-03
(160 days)
Product Code
JWH, PAN
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
SIGNAL MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications.
1. Osteoarthritis (for cemented use only)
2. Rheumatoid Arthritis (for cemented use only)
3. Traumatic Arthritis (for cemented use only)
4. Where the use of a more conservative procedure has failed or is unacceptable.
Device Description
The Symmetric™ Total Knee System is intended for the resurfacing of the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem) and a polyethylene tibial insert and patellar component.
The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo). The femoral component will be available in eight sizes (1-8) and will have a central post (with a 5° valgus angle) and gussets to aid in rotational stability and to increase strength. It will be plasma sprayed with Commercially Pure Titanium (CPTi).
The TIBIAL TRAY is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti 6Al-4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside broviding rotational stabilization and increased tray strength. Four screw holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 8 sizes (1-8) and is plasma sprayed with Commercially Pure Titanium (CPTi).
The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semiconstrained and is captured in the tibial tray by the mating capture features. The insert is available in nine thicknesses (10, 12, 14, 16, 18, 20, 25, 30, 35mm) and 8 sizes (1-8).
The METAPHYSEAL STEM is designed to be driven onto a tibial tray further increasing the fit and fill of the component allowing for a more stable system.
The REVISION STEM is designed to be driven onto a tibial tray or femoral component further increasing the stability of a revision component.
The PATELLAR COMPONENT is dome shaped and tracks nicely against the femoral component.
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