FDA.reportPublic FDA data

Titan™

Primary DI
10381780116226
Brand
Titan™
Company
Ascension Orthopedics, Inc.
Model
HRA9005221WW
Catalog number
HRA-900-52/21-WW
Device description
Humeral Resurfacing Arthroplasty
Published
2017-10-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062861000
K071064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062861000ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEMAscension Orthopedics, Inc.2006-10-31HSD
K071064000ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HAAscension Orthopedics, Inc.2007-06-22HSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780116226PrimaryGS10
M268HRA9005221WW1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011622610381780116226

GMDN Terms#

Term, Definition table
TermDefinition
Resurfacing humeral head prosthesisA sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that is placed over (resurfaces) a surgically-prepared humeral head, and may be used with a cementless stem.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26