FDA.reportPublic FDA data

OsseoFit™ Stemless Shoulder

Primary DI
00889024679313
Brand
OsseoFit™ Stemless Shoulder
Company
Zimmer, Inc.
Model
00-5381-010-22
Catalog number
00-5381-010-22
Published
2024-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKCProsthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241873000OsseoFit Stemless Shoulder SystemZimmer, Inc.2024-12-11PKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024679313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024679313008890246793138890246793130889024679313

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
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
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556915943AETOS Shoulder SystemSmith & Nephew, Inc.PKC2026-05-18
B1132G1HB300010Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
B1132G1HB300020Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
00885556910122AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910139AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910146AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910153AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919361AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919378AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919392AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919446AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00887868580802IDENTITY HumeralZimmer, Inc.PKC2025-10-10
03701037320426EasyTech AnatomicalFX SOLUTIONSPKC2025-03-03
03701037321010FX V135FX SOLUTIONSPKC2025-02-20
03701037321027FX V135FX SOLUTIONSPKC2025-02-20
03701037321034FX V135FX SOLUTIONSPKC2025-02-20
03701037321041FX V135FX SOLUTIONSPKC2025-02-20
03701037321058FX V135FX SOLUTIONSPKC2025-02-20
03701037321065FX V135FX SOLUTIONSPKC2025-02-20
03701037321072FX V135FX SOLUTIONSPKC2025-02-20
03701037321089FX V135FX SOLUTIONSPKC2025-02-20
03701037321096FX V135FX SOLUTIONSPKC2025-02-20
03701037321102FX V135FX SOLUTIONSPKC2025-02-20
00889024678736OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678743OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678750OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678767OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678774OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678781OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18