# K242477: Shoulder Soft Tissue Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: May 12, 2025 after 264 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: 10 generations back to K961555 (1996). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152566: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor,  HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors, Smith & Nephew, Inc. (2015) Summary page 5.
- K113297: Knotilus Anchor System, T.A.G. Medical Products Corporation, Ltd. (2012) Summary page 5.
- K173269: KATOR Suture Anchor, Kator, LLC (2018) Summary page 5.
- K113294: Smith & Nephew Healicoil PK Suture Anchor, Smith & Nephew, Inc. (2012) Summary page 5.

## Indications for use
Components of the Signature Orthopaedics range of soft tissue fixation devices are intended to reattach ligament, tendon or soft tissue to bone. Specifically, the Bl-ON Screw and Anchor, Bl-ON Bio-screw and Bio-anchor, Vector Knotted, ATOK, Vortex Anchor, Dynaloc Anchor and Shoulder Suture Anchor are indicated for use in the shoulder, including: Shoulder • Capsular stabilizaton o Bankart Repair o Anterior shoulder instability o SLAP lesion repairs o Capsular shift or capsulolabral reconstructons • Acromioclavicular separaton repairs • Deltoid repairs • Rotator cuff tear repairs • Biceps tenodesis

Source page: https://510kreport.com/device/K242477
Methodology: https://510kreport.com/methodology