FDA.reportPublic FDA data

SAIPH®

Primary DI
05055455519626
Brand
SAIPH®
Company
MATORTHO LTD
Model
293-749
Catalog number
293-749
Device description
Saiph® Trial Bearing Blue. Left.12mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
Published
2021-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140222000SAIPH KNEE SYSTEMMatortho2014-11-17JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055455519626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055455519626050554555196265055455519626

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
216819863
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055455518285SAIPH®293-202293-2002021-01-14
05055455517714SAIPH®290-030290-0302021-01-18
05055455517721SAIPH®290-050290-0502021-01-18
05055455517738SAIPH®290-051290-0512021-01-18
05055455517745SAIPH®290-052290-0522021-01-18
05055455517752SAIPH®290-053290-0532021-01-18
05055455517769SAIPH®290-160290-1602021-01-18
05055455517776SAIPH®290-161290-1612021-01-18
05055455517783SAIPH®290-162290-1622021-01-18
05055455517837SAIPH®290-181290-1812021-01-18
05055455517899SAIPH®290-187290-1872021-01-18
05055455518049SAIPH®293-004293-0042021-01-18
05055455518056SAIPH®293-005293-0052021-01-18
05055455518063SAIPH®293-006293-0062021-01-18
05055455518070SAIPH®293-007293-0072021-01-18
05055455518087SAIPH®293-025293-0252021-01-18
05055455518094SAIPH®293-026293-0262021-01-18
05055455518124SAIPH®293-029293-0292021-01-18
05055455518131SAIPH®293-030293-0302021-01-18
05055455518148SAIPH®293-031293-0312021-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29
03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29
03701089517614TRAXAMPLITUDE SASJWH2026-07-29
03701089517621TRAXAMPLITUDE SASJWH2026-07-29
03701089517638TRAXAMPLITUDE SASJWH2026-07-29
03701089517645TRAXAMPLITUDE SASJWH2026-07-29
03701089517652TRAXAMPLITUDE SASJWH2026-07-29
03701089517669TRAXAMPLITUDE SASJWH2026-07-29
03701089518390TRAXAMPLITUDE SASJWH2026-07-29
03701089518406TRAXAMPLITUDE SASJWH2026-07-29
03701089518413TRAXAMPLITUDE SASJWH2026-07-29
03701089518420TRAXAMPLITUDE SASJWH2026-07-29
03701089518437TRAXAMPLITUDE SASJWH2026-07-29
03701089518444TRAXAMPLITUDE SASJWH2026-07-29