FDA.reportPublic FDA data

APTUS

Primary DI
07630894821080
Brand
APTUS
Company
Medartis AG
Model
A-5042.51/4S
Catalog number
A-5042.51/4S
Device description
1.8 K-Wire, Lancet, 150mm, 4/Pkg
Published
2024-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDFGUIDE, NEEDLE, SURGICAL
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092038000
K243610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092038000APTUS K-WIRE SYSTEMMedartis AG2009-09-23HTY
K243610000APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG2025-03-07HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630008402914PreviousGS10
07630037864202PrimaryGS10
07630037864226PrimaryGS10
07630037864233PrimaryGS10
07630894821080Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630008402914076300084029147630008402914
07630037864202076300378642027630037864202
07630037864226076300378642267630037864226
07630037864233076300378642337630037864233
07630894821080076308948210807630894821080

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. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a 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 material that is not chemically degraded or absorbed by natural body processes (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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
4
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894829819APTUSA-5788.12/1SA-5788.12/1S2026-06-01
07630894829826APTUSA-5788.14/1SA-5788.14/1S2026-06-01
07630894829833APTUSA-5788.16/1SA-5788.16/1S2026-06-01
07630894829840APTUSA-5788.18/1SA-5788.18/1S2026-06-01
07630894829857APTUSA-5788.20/1SA-5788.20/1S2026-06-01
07630894829864APTUSA-5788.22/1SA-5788.22/1S2026-06-01
07630894829871APTUSA-5788.24/1SA-5788.24/1S2026-06-01
07630894829888APTUSA-5788.26/1SA-5788.26/1S2026-06-01
07630894829895APTUSA-5788.28/1SA-5788.28/1S2026-06-01
07630894829901APTUSA-5788.30/1SA-5788.30/1S2026-06-01
07630894829918APTUSA-5788.32/1SA-5788.32/1S2026-06-01
07630894829925APTUSA-5788.34/1SA-5788.34/1S2026-06-01
07630894829932APTUSA-5788.36/1SA-5788.36/1S2026-06-01
07630894829949APTUSA-5788.38/1SA-5788.38/1S2026-06-01
07630894829956APTUSA-5788.40/1SA-5788.40/1S2026-06-01
07630894829963APTUSA-5788.42/1SA-5788.42/1S2026-06-01
07630894829970APTUSA-5788.44/1SA-5788.44/1S2026-06-01
07630894829987APTUSA-5788.46/1SA-5788.46/1S2026-06-01
07630894829994APTUSA-5788.48/1SA-5788.48/1S2026-06-01
07630894830006APTUSA-5788.50/1SA-5788.50/1S2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894830822APTUSMedartis AGHTY2026-06-01
07630894830839APTUSMedartis AGHTY2026-06-01
07630894830884APTUSMedartis AGHTY2026-06-01
07630894830891APTUSMedartis AGHTY2026-06-01
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
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2024-09-19
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