FDA.reportPublic FDA data

SMR STEMLESS

Primary DI
08033390108133
Brand
SMR STEMLESS
Company
LIMACORPORATE SPA
Model
9013.55.053
Catalog number
9013.55.053
Device description
SMR STEMLESS - Reamer Small
Published
2023-05-26
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
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
K221758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221758000SMR Stemless AnatomicLima Corporate S.P.A.2023-03-17PKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390108133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390108133080333901081338033390108133

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
432066322
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19
08033390002257SMR System1362.09.0201362.09.0202026-02-19
08033390050029SMR System1362.09.1151362.09.1152026-02-19
08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19

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