FDA.reportPublic FDA data

APTUS

Primary DI
07630037863977
Brand
APTUS
Company
Medartis AG
Model
A-5040.51/2S
Catalog number
A-5040.51/2S
Device description
1.8 K-Wire, Trocar, 150mm
Published
2025-07-31
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
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243610000APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG2025-03-07HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037863977PrimaryGS10
07630894821097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037863977076300378639777630037863977
07630894821097076308948210977630894821097

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Regulatory Flags#

DUNS number
480054895
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630037894865APTUSA-4750.95A-4750.952023-02-24
07630008470937APTUSA-4750.95A-4750.952015-10-24
07630894829079APTUSA-2065A-20652026-01-09
07630037863946APTUSA-5040.42/1SA-5040.42/1S2024-11-03
07630894829062APTUSA-2056A-20562025-12-15
07630037862673APTUSA-4200.43SA-4200.43S2024-11-03
07630037862635APTUSA-4200.41SA-4200.41S2024-11-03
07630037862659APTUSA-4200.42SA-4200.42S2024-11-03
07630037890430APTUSA-4750.192SA-4750.192S2023-03-03
07630037891314APTUSA-4854.01SA-4854.01S2023-03-03
07630037891345APTUSA-4854.04SA-4854.04S2023-03-03
07630037891352APTUSA-4854.05SA-4854.05S2023-03-03
07630037891369APTUSA-4854.06SA-4854.06S2023-03-03
07630037892199APTUSA-4954.03SA-4954.03S2023-03-03
07630037892236APTUSA-4954.07SA-4954.07S2023-03-03
07630037892311APTUSA-4954.13SA-4954.13S2023-03-03
07630037892328APTUSA-4954.14SA-4954.14S2023-03-03
07630037892335APTUSA-4954.15SA-4954.15S2023-03-03
07630037892366APTUSA-4954.18SA-4954.18S2023-03-03
07630037892380APTUSA-4954.20SA-4954.20S2023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHHTY2024-04-12
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHHTY2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202327Drill S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202334Drill S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202365Tray SF Push-in Anchor PortfolioSurgical Fusion Technologies GmbHHTY2024-04-12
07630037863854APTUSMedartis AGHTY2024-03-22
07630037863915APTUSMedartis AGHTY2024-03-22
07630037864196APTUSMedartis AGHTY2024-03-22
07630037864226APTUSMedartis AGHTY2024-03-22
07630037864233APTUSMedartis AGHTY2024-03-22
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHHTY2024-02-06
07649990202082Handpiece SupraFuserSurgical Fusion Technologies GmbHHTY2024-02-05
07649990202358Footswitch SupraFuserSurgical Fusion Technologies GmbHHTY2024-02-05