# K133579: Multifilament Stainless Steel Sutures with Crimps

- Pathway: 510(k) (Traditional)
- Applicant: Pontis Orthopaedics, LLC
- Decided: Jun 26, 2014 after 217 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K792022 (1979). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041115: Gii Quickanchor Plus, Depuy Mitek, A Johnson & Johnson Company (2004) Summary page 1.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 1.
- K081098: Endobutton Continuous Loop (CL), Smith & Nephew Inc., Endoscopy Division (2008) Summary page 1.
- K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5, Core Essence Orthopaedics, LLC (2008) Summary page 1.
- K993286: Pioneer Silicoat Sternal Cable, Pioneer Surgical Technology (1999) Summary page 1.

## Indications for use
Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist -scapho-lunate approximation.

Source page: https://510kreport.com/device/K133579
Methodology: https://510kreport.com/methodology