Ascension® Silicone PIP

Primary DI
10381780116295
Brand
Ascension® Silicone PIP
Company
Ascension Orthopedics, Inc.
Model
SPIP5200WW
Catalog number
SPIP-520-0-WW
Device description
The Ascension silicone PIP is an anatomically designed, single use, one piece, flexible hinge prosthesis designed to be implanted without bone cement across the proximal interphalangeal (PIP) joint. It is made from medical grade silicone elastomer. The proximal and distal stems of the prosthesis are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. the PIP provides 90 degrees of flexion from full extension. The Ascension PIP finger joint prostheses is intended for cementless replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis.
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
KYJPROSTHESIS, FINGER, CONSTRAINED, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYJProsthesis, Finger, Constrained, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082231000ASCENSION SILICONE PIPAscension Orthopedics, Inc.2009-01-12KYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780116295PrimaryGS10
M268SPIP5200WW1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011629510381780116295

GMDN Terms#

Term, Definition table
TermDefinition
Proximal interphalangeal joint prosthesis, modularA sterile, implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. The device typically consists of proximal and distal metal (e.g., titanium) stems, which may be coated with a material (e.g., hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth, for insertion into the prepared phalanges of the joint. The stems may have articulating surfaces or there may be separate metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic ( e.g., polyethylene) articulating surface components. Dedicated tools for implantation may be included.

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

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