FDA.reportPublic FDA data

Integra®

Primary DI
10381780235040
Brand
Integra®
Company
Ascension Orthopedics, Inc.
Model
PYROLUNINSTP
Device description
The Integra Lunate system is intended for replacement of the lunate bone in the proximal carpal row of the wrist. The set includes five trials to evaluate the size and fit of the implant. Five sizing templates are also included to assess coverage and establish proper sizing for the component.
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWNPROSTHESIS, WRIST, CARPAL LUNATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWNProsthesis, Wrist, Carpal LunateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080997000ASCENSION PYROCARBON LUNATEAscension Orthopedics, Inc.2008-06-17KWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780235040PrimaryGS10
M268PYROLUNINSTP1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178023504010381780235040

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
942377524
Device count
1
Kit
true
Serial number
true
Sterilization required before use
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
00885556858721PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858738PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858745PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858752PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858769PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858820PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858837PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858844PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858851PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858868PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
M5288W122217W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W123517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152217W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152223W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153523W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W950016W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W122217A0HemiCAPITATETMARTHROSURFACE INCORPORATEDKWN2018-04-16
00887868239830Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239847Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239854Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
10381780116240Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116257Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116264Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116271Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116288Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780236795Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236801Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236818Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236825Integra®Ascension Orthopedics, Inc.KWN2016-08-15