Emerson 5X00062G01 Ovation analog output module

Emerson 5X00062G01 Ovation analog output module

Technical data of product parameters

CMS could not identify information in the application confirming that bio-ConneKt® Wound
Matrix and OrthoNovis are identical products. The bio-ConneKt® Wound Matrix product has 5X00062G01
received 510(k) clearance from the FDA, which was included as part of its HCPCS Level II
application. CMS would expect OrthoNovis to receive similar clearance from the FDA. As a
result, we are unable to revise existing HCPCS Level II code Q4161 “Bio-connekt wound
matrix, per square centimeter” to include OrthoNovis in the code descriptor.MLM Biologics, Inc. respectfully disagreed with CMS’ published preliminary 5X00062G01
recommendation and requested that the HCPCS code Q4161 with the descriptor “bioConneKt Wound Matrix, per sq. cm.” be modified to include a private label product that is
produced for an outside company. The private label OrthoNovis Connect is manufactured
exactly the same as bio-ConneKt® with the same existing FDA 510(k) cleared indications. 5X00062G01
According to the applicant, all raw material, chemical processing, and manufacturing of
OrthoNovis Connect is exactly the same as bio-ConneKt®. If CMS changes the descriptor of
Q4161, nothing will change except for the name on the private label, and MLM Biologics,
Inc. will continue to market the existing bio-ConneKt® Wound Matrix product.We appreciate the comments provided in response to CMS’ published preliminary
recommendation. Based on the information provided in the application to revise an existing
HCPCS Level II code, and after consideration of the comments we received, CMS has
determined that device listings should include all of the current proprietary names that are
used to market the devices in the United States. As a result, CMS is denying the request to 5X00062G01
revise existing code Q4161. The applicant is encouraged to review the FDA’s requirements
for device distributions in the United States. The applicant is welcome to submit a new
HCPCS Level II coding application in a subsequent biannual coding cycle.

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