FDA.reportPublic FDA data

Subtalar implant, non-bioabsorbable

Definition
A device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).
GUDID devices
38
Last updated
2023-07-25 09:40:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00885556865880Subtalar MBA Implant SystemSmith & Nephew, Inc.0501082022-12-22
00885556865897Subtalar MBA Implant SystemSmith & Nephew, Inc.0501092022-12-22
00885556865903Subtalar MBA Implant SystemSmith & Nephew, Inc.0501102022-12-19
00885556865910Subtalar MBA Implant SystemSmith & Nephew, Inc.0501122022-12-19
04048266162960MC-Subtalar™ IIMerete GmbH6 25 T202016-06-10
04048266162977MC-Subtalar™ IIMerete GmbH8 25 T202016-06-10
04048266162984MC-Subtalar™ II Merete GmbH10 25 T202016-06-10
04048266162991MC-Subtalar™ II Merete GmbH6 30 T20 2016-06-10
04048266163004MC-Subtalar™ II Merete GmbH8 30 T20 2016-06-10
04048266163011MC-Subtalar™ II Merete GmbH10 30 T202016-06-10
04048266163028MC-Subtalar™ IIMerete GmbH6 35 T202016-06-10
04048266163035MC-Subtalar™ IIMerete GmbH8 35 T202016-06-10
04048266163042MC-Subtalar™ II Merete GmbH10 35 T20 2016-06-10
10381780048152KALIX IINEWDEAL141009ND2015-09-24
10381780048169KALIX IINEWDEAL141010ND2015-09-24
10381780119937Integra® TruArch®Ascension Orthopedics, Inc.TA08002017-10-09
10381780119944Integra® TruArch®Ascension Orthopedics, Inc.TA09002017-10-09
10381780119951Integra® TruArch®Ascension Orthopedics, Inc.TA10002017-10-09
10381780119968Integra® TruArch®Ascension Orthopedics, Inc.TA11002017-10-09
10381780119975Integra® TruArch®Ascension Orthopedics, Inc.TA12002017-10-09
M248141011ND1KALIX IINEWDEAL141011ND2015-09-24
M248141012ND1KALIX IINEWDEAL141012ND2015-09-24
M248141013ND1KALIX IINEWDEAL141013ND2015-09-24
M248141014ND1KALIX IINEWDEAL141014ND2015-09-24
M248141015ND1KALIX IINEWDEAL141015ND2015-09-24
M248141017ND1KALIX IINEWDEAL141017ND2015-09-24
M209170850HORIZON HYBRID SUBTALAR 8MMBIOPRO, INC.170852015-12-28
M209170860HORIZON HYBRID SUBTALAR 9MMBIOPRO, INC.170862015-12-28
M209170870HORIZON HYBRID SUBTALAR 10MMBIOPRO, INC.170872015-12-28
M209170880HORIZON HYBRID SUBTALAR 11MMBIOPRO, INC.170882015-12-28
M209170890HORIZON HYBRID SUBTALAR 12MMBIOPRO, INC.170892015-12-28
M209172210HORIZON TITANIUM SUBTALAR 8MMBIOPRO, INC.172212015-12-28
M209172220HORIZON TITANIUM SUBTALAR 9MMBIOPRO, INC.172222015-09-16
M209172230HORIZON TITANIUM SUBTALAR 10MMBIOPRO, INC.172232015-09-16
M209172240HORIZON TITANIUM SUBTALAR 11MMBIOPRO, INC.172242015-09-16
M209172250HORIZON TITANIUM SUBTALAR 12MMBIOPRO, INC.172252015-09-16
M209174780HORIZON TITANIUM SUBTALAR 6MMBIOPRO, INC.174782015-09-16
M209178030HORIZON TITANIUM SUBTALAR 7MMBIOPRO, INC.178032015-09-16