FDA.reportPublic FDA data

TARA FEMORAL COMPONENT 55

Primary DI
M209100930
Brand
TARA FEMORAL COMPONENT 55
Company
BIOPRO, INC.
Model
10093
Published
2016-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXAProsthesis, Tendon, Passive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXAProsthesis, Tendon, PassiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043542000BIOPRO TARA FEMORAL RESURFACING COMPONENTBiopro, Inc.2005-05-18KXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209100930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resurfacing metallic hip prosthesisAn implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100124843502.5 x 19mm HBS Screw195542021-06-14
00810012485852Horizon Subtalar Gen 2 - 11mm Implant226472019-06-12
00810012483797DRILL GUIDE 15 18MM176502019-06-10
00810012484183MEASURING SLEEVE186582019-06-06
00810012485364MPJ TRIAL 20mm (MD)122362019-06-06
00810012484879HBS SCREW 3.0 X 16MM SDST205192019-06-05
00810012481830GOEZ SCREW 4.0 X 50MM190502019-06-04
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20918608010mm HBS® Standard Compression186082015-09-16
M20918609011mm HBS® Standard Compression186092015-09-16
M20918610012mm HBS® Standard Compression186102015-09-16
M20918611013mm HBS® Standard Compression186112015-09-16
M20918612014mm HBS® Standard Compression186122015-09-16
M20918613015mm HBS® Standard Compression186132015-09-16
M20918614016mm HBS® Standard Compression186142015-09-16
M20918615017mm HBS® Standard Compression186152015-09-16
M20918616018mm HBS® Standard Compression186162015-09-16
M20918617019mm HBS® Standard Compression186172015-09-16
M20918618020mm HBS® Standard Compression186182015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700751502132Universal Tendon SpacerASKORN MEDICALHXA2025-04-20
B051427030Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427040Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427050Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427060Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
00840420188373SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188380SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188397SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188403SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420188410SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420197795SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130662SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130679SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130686SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420130693SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-09-17
00840420186782HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
00840420186799HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
00840420193018HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
00840420193100HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2016-07-29
00840420132246HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132253HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132260HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132277HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132284HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-24
00840420132192HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121851HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121868HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121875HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121882HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420132147HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15