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 not intended for arthrodesis/joint fusion. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).
GUDID devices
27
Last updated
2026-09-04 23:13:04

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00885556865873Subtalar MBA Implant SystemSmith & Nephew, Inc.0501062022-12-19
08053782783755Bioplan Titanium implantBRM EXTREMITIES SRLBioplan Titanium implant 72026-08-14
08053782783762Bioplan Titanium implantBRM EXTREMITIES SRLBioplan Titanium implant 82026-08-14
08053782783779Bioplan Titanium implantBRM EXTREMITIES SRLBioplan Titanium implant 92026-08-14
08053782783786Bioplan Titanium implantBRM EXTREMITIES SRLBioplan Titanium implant 102026-08-14
08053782783793Bioplan Titanium implantBRM EXTREMITIES SRLBioplan Titanium implant 112026-08-14
08053782783809Bioplan Titanium implantBRM EXTREMITIES SRLBioplan Titanium implant 122026-08-14
08053782783816Bioplan Titanium implantBRM EXTREMITIES SRLBioplan Titanium implant 132026-08-14
10381780048176KALIX IINEWDEAL141011ND2015-09-24
10381780048183KALIX IINEWDEAL141012ND2015-09-24
10381780048190KALIX IINEWDEAL141013ND2015-09-24
10381780048206KALIX IINEWDEAL141014ND2015-09-24
10381780048213KALIX IINEWDEAL141015ND2015-09-24
10381780048220KALIX IINEWDEAL141017ND2015-09-24
10381780065494MBA™ Titanium Subtalar Implant SystemAscension Orthopedics, Inc.0501062017-10-09
10381780065500MBA™ Titanium Subtalar Implant SystemAscension Orthopedics, Inc.0501082017-10-09
10381780065517MBA™ Titanium Subtalar Implant SystemAscension Orthopedics, Inc.0501092017-10-09
10381780065524MBA™ Titanium Subtalar Implant SystemAscension Orthopedics, Inc.0501102017-10-09
10381780065531MBA™ Titanium Subtalar Implant SystemAscension Orthopedics, Inc.0501122017-10-09
10381780066552bioBLOCK® Subtalar Implant SystemAscension Orthopedics, Inc.0400082017-10-09
10381780066569bioBLOCK® Subtalar Implant SystemAscension Orthopedics, Inc.0400092017-10-09
10381780066576bioBLOCK® Subtalar Implant SystemAscension Orthopedics, Inc.0400102017-10-09
10381780066583bioBLOCK® Subtalar Implant SystemAscension Orthopedics, Inc.0400112017-10-09
10381780066590bioBLOCK® Subtalar Implant SystemAscension Orthopedics, Inc.400122017-10-09
10381780074342Integra® TruArch®Ascension Orthopedics, Inc.TRUARCHIMP2015-09-22
10381780257288MBA™Ascension Orthopedics, Inc.MBASET2016-07-25
10381780441380MBA™ Titanium Subtalar Implant SystemAscension Orthopedics, Inc.MBAIMP2018-05-11