PyroCarbon PIP Total Joint System

Primary DI
00885556858455
Brand
PyroCarbon PIP Total Joint System
Company
Smith & Nephew, Inc.
Model
PIP-200-40D-WW
Catalog number
PIP-200-40D-WW
Device description
PIP SZ. 40 DISTAL
Published
2023-02-10
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
OMXHigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H010005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H010005000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556858455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556858455008855568584558855568584550885556858455

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556858394PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858400PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858417PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858424PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858431PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858448PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858462PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
10381780000464Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000471Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000488Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000495Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000501Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000518Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000525Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000532Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20010PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20020PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20030PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20040PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20010DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20020DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20030DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20040DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18