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PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

by Science & Bio Materials (S.B.M.) Sas

510(k) K250844

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250844↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250844 Date2 Jun 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MBI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pullup Clip; BT Loop; Pullup Tex Clip; Rigidloop T; Rigidloop Clip; Rigidloop BTB; and Rigidloop Suture Loop are orthopedic suture anchors and loop devices designed to secure soft tissue to bone. These devices are intended for use in orthopedic procedures, providing a rigid or flexible loop mechanism to facilitate tension-free fixation and reduce suture pull-out.

These devices are supplied as single-use orthopedic implants and are regulated under FDA 510(k) clearance (K250844) and the EU Medical Device Regulation (MDR). They are classified under product code MBI and are intended for use in orthopedic settings, with no specific MRI safety classification noted. Storage and handling follow standard sterile medical device protocols.

Other devices from Science & Bio Materials (S.B.M.) Sas

  • ecoFIX®

    Class II

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of orthopedic procedures are these suture anchors and loop devices intended for securing soft tissue to bone?

    These devices—including the Pullup Clip, BT Loop, Pullup Tex Clip, Rigidloop T, Rigidloop Clip, Rigidloop BTB, and Rigidloop Suture Loop—are designed for orthopedic procedures where soft tissue must be securely attached to bone. They provide either rigid or flexible loop mechanisms to create tension-free fixation, reducing the risk of suture pull-out during healing. They are not indicated for any specific procedure but are broadly applicable in orthopedic surgeries requiring soft tissue-to-bone stabilization.

  • Are these devices reusable, or are they meant for single-use only?

    These devices are explicitly labeled as single-use orthopedic implants. They are not intended for reuse after a single surgical procedure, as reuse could compromise sterility and structural integrity, potentially compromising patient safety.

  • How should these suture anchors and loops be stored to maintain their sterility and functionality?

    Since these devices are sterile implants, they must be stored following standard sterile medical device protocols. This typically includes keeping them in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use to preserve sterility and prevent contamination.

  • Are there different sizes or models available for these devices, and how do they differ?

    Yes, the product line includes multiple models, each designed for specific clinical applications: the Pullup Clip, BT Loop, and Pullup Tex Clip offer flexible or semi-rigid fixation, while the Rigidloop T, Rigidloop Clip, Rigidloop BTB, and Rigidloop Suture Loop provide more rigid loop mechanisms. Exact sizing details (e.g., loop diameter, anchor dimensions) are not specified in the data, but the variety suggests they cater to different anatomical sites or tissue types requiring varying degrees of tension and stability.

  • What regulatory pathways have these devices undergone, and how does that affect their use in the U.S. and EU?

    In the U.S., these devices have undergone FDA 510(k) clearance (K250844), meaning they are deemed substantially equivalent to a legally marketed predicate device and are legally marketable under FDA regulations. In the EU, they comply with the EU Medical Device Regulation (MDR), ensuring they meet EU safety, performance, and clinical requirements. Both pathways confirm their suitability for orthopedic use but do not imply any specific clinical indication beyond what is stated in the description.