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510(k) Data Aggregation
K Number
K223122Device Name
MENIX®; MENIX® DUO
Manufacturer
S.B.M. SAS (Science & Bio Materials)
Date Cleared
2023-08-03
(304 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
**S.B.M. SAS (Science **& Bio Materials)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MENIX® / MENIX® DUO Meniscal Suture Systems are indicated for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The MENIX® DUO systems are indicated for use in meniscal repairs and allograft transplant procedures. The MENIX® / MENIX® DUO systems are intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The MENIX ® / MENIX® DUO devices are intended for single use only.
Device Description
The MENIX® / MENIX® DUO devices are intended to be used for all-inside meniscal repair:
- The MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.
- MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.
Each anchor is pre-mounted on a needle to allow its deployment through the meniscus by pressing on the associated button. A transparent sheath acts as a penetration depth limiter and as a protection for users. As the MENIX® meniscal suture system consists of only one anchor associated with a suture, this suture must be tied to another MENIX® / MENIX® DUO meniscal suture system. The devices are supplied sterile, individually packaged and ready to use
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K Number
K202193Device Name
PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
Manufacturer
S.B.M. SAS (Science & Bio Materials)
Date Cleared
2020-10-16
(72 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
**S.B.M. SAS (Science **& Bio Materials)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PULLUP® BTB, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.
Device Description
The device is proposed in the following variants:
- -PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft.
- PULLUP® BTB: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft.
- -BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that must be mounted on the GraftTech® preparation station.
- -PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device.
Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.
The implants are supplied sterile, individually packaged, ready to use.
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