FDA.reportPublic FDA data

Modal Total Hip System

Primary DI
B035MEBS65151
Brand
Modal Total Hip System
Company
MODAL MANUFACTURING LLC
Model
M-EBS-6515
Device description
Bone Screw, 6.5mm X 15mm
Published
2018-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151424000The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC2016-07-27LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B035MEBS65151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metal-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081983825
Device count
1
Lot or batch
true
Expiration date on label
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
00889024707160G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24