FDA.reportPublic FDA data

X-Twist Biocomposite Suture Anchor

Primary DI
00816342025515
Brand
X-Twist Biocomposite Suture Anchor
Company
PARCUS MEDICAL LLC
Model
XT46200
Device description
X-Twist BC 6.25mm, 1xNo.2 Suture
Published
2025-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232513000X-Twist Biocomposite Suture AnchorParcus Medical2023-09-18MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816342025515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342025515008163420255158163420255150816342025515

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859961950
Device count
1
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
00816342022033Graft Fixation System200422025-09-16
00816342022040Graft Fixation System200492025-09-16
00816342022057Graft Fixation System200532025-09-16
00816342022064Graft Fixation System200542025-09-16
00816342022071Graft Fixation System200552025-09-16
00816342022088Graft Fixation System200562025-09-16
00816342022095Graft Fixation System200592025-09-16
00816342022101Graft Fixation System200602025-09-16
00816342023887Graft Fixation System200462025-09-16
00816342023900Graft Fixation System200502025-09-16
00816342023955Graft Fixation System20042S2025-09-16
00816342024204Graft Fixation System20049S2025-09-16
00816342024211Graft Fixation System20035S2025-09-16
00816342024228Graft Fixation System20055S2025-09-16
00816342024235Graft Fixation System20054S2025-09-16
00816342024242Graft Fixation System20059S2025-09-16
00816342024259Graft Fixation System20053S2025-09-16
00816342024266Graft Fixation System20056S2025-09-16
00816342024273Graft Fixation System20032S2025-09-16
00816342024280Graft Fixation System20034S2025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHMAI2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHMAI2025-10-01
07613327662016KNOTILUS+STRYKER CORPORATIONMAI2025-06-16
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
10886705033317GRYPHON XMedos International SàrlMAI2025-04-22
10886705001040LUPINEDEPUY MITEK, LLCMAI2025-03-04
10886705023868HEALIX TRANSTENDMedos International SàrlMAI2025-03-04
07613327547429DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547436DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547443DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547450DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547467DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
10845854045794CROSSFT, HI-FIConmed CorporationMAI2024-04-18
20653405988646Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988653ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988660ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988677Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988684ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988691ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHMAI2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12