OPRA Implant System

FDA Premarket Approval P190009

Pre-market Approval Supplement Details

The opra implant system is indicated for patients who have transfemoral amputation due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The opra implant system is intended for skeletally mature patients. The patient failed to receive benefit from socket prostheses or is expected to not tolerate socket use due to problems such as:• recurrent skin infections and ulcerations in the socket contact area• pain• a short stump preventing the use of socket prosthesis• volume fluctuation in the stump• soft tissue scarring• extensive area of skin grafting• socket retention problems due to excessive perspiration• restricted mobility

DeviceOPRA Implant System
Generic NameOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
ApplicantIntegrum AB
Date Received2019-04-05
Decision Date2020-12-18
PMAP190009
SupplementS
Product CodePJY 
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address Integrum AB krokslatts Fabriker 50 molndal Se-43-431

Supplemental Filings

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Supplement NumberDateSupplement Type
P190009Original Filing

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