FDA.reportPublic FDA data

OVOMotion™

Primary DI
M5288HM24844A0
Brand
OVOMotion™
Company
ARTHROSURFACE INCORPORATED
Model
8HM2-4844-A
Catalog number
8HM2-4844-A
Device description
Humeral Component, 48mm x 44mm, OVOMotion
Published
2018-11-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173964000OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.2018-04-18HSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5288HM24844A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder humeral body prosthesisA sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.

Contacts#

Phone, Email table
PhoneEmail
508-520-3003contact@arthrosurface.com

Regulatory Flags#

DUNS number
144666109
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5288RB42310A0RevoMotion 8RB4-2310-A2026-05-21
M5288RG032ECA0RevoMotion 8RG0-32EC-A2026-05-21
M5288RG03600A0RevoMotion 8RG0-3600-A2026-05-21
M5288RG036ECA0RevoMotion 8RG0-36EC-A2026-05-21
M5288RG04000A0RevoMotion 8RG0-4000-A2026-05-21
M5288RG040ECA0RevoMotion 8RG0-40EC-A2026-05-21
M5288RG23200A0RevoMotion 8RG2-3200-A2026-05-21
M5288RG232ECA0RevoMotion 8RG2-32EC-A2026-05-21
M5288RG23600A0RevoMotion 8RG2-3600-A2026-05-21
M5288RG236ECA0RevoMotion 8RG2-36EC-A2026-05-21
M5288RG24000A0RevoMotion 8RG2-4000-A2026-05-21
M5288RG240ECA0RevoMotion 8RG2-40EC-A2026-05-21
M5288RG43200A0RevoMotion 3RG4-3200-A2026-05-21
M5288RG43600A0RevoMotion 8RG4-3600-A2026-05-21
M5288RG44000A0RevoMotion 8RG4-4000-A2026-05-21
M5288RM20600A0RevoMotion 8RM2-0600-A2026-05-21
M5288RM20800A0RevoMotion 8RM2-0800-A2026-05-21
M5288RM21000A0RevoMotion 8RM2-1000-A2026-05-21
M5288RM21200A0RevoMotion 8RM2-1200-A2026-05-21
M5288RM21400A0RevoMotion 8RM2-1400-A2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26