FDA.reportPublic FDA data

Modal Total Knee System

Primary DI
B035M321100041
Brand
Modal Total Knee System
Company
MODAL MANUFACTURING LLC
Model
M-3211-0004
Device description
Tibial Tray Trial Sz 4
Published
2018-04-30
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
K142649000
K150783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142649000Progressive Orthopedic Total Knee SystemThe Progressive Orthopaedic Company, LLC2015-03-24JWH
K150783000Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC2015-06-23JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B035M321100041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. 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
081983825
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B035M311111011Modal Total Knee SystemM-3111-11012018-04-30
B035M311111021Modal Total Knee SystemM-3111-11022018-04-30
B035M311111031Modal Total Knee SystemM-3111-11032018-04-30
B035M311111041Modal Total Knee SystemM-3111-11042018-04-30
B035M311111051Modal Total Knee SystemM-3111-11052018-04-30
B035M311111061Modal Total Knee SystemM-3111-11062018-04-30
B035M311112011Modal Total Knee SystemM-3111-12012018-04-30
B035M311112021Modal Total Knee SystemM-3111-12022018-04-30
B035M311112031Modal Total Knee SystemM-3111-12032018-04-30
B035M311112041Modal Total Knee SystemM-3111-12042018-04-30
B035M311112051Modal Total Knee SystemM-3111-12052018-04-30
B035M311112061Modal Total Knee SystemM-3111-12062018-04-30
B035M311121011Modal Total Knee SystemM-3111-21012018-04-30
B035M311121021Modal Total Knee SystemM-3111-21022018-04-30
B035M311121031Modal Total Knee SystemM-3111-21032018-04-30
B035M311121041Modal Total Knee SystemM-3111-21042018-04-30
B035M311121051Modal Total Knee SystemM-3111-21052018-04-30
B035M311121061Modal Total Knee SystemM-3111-21062018-04-30
B035M311122011Modal Total Knee SystemM-3111-22012018-04-30
B035M311122021Modal Total Knee SystemM-3111-22022018-04-30

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