# K171964: LigaMetrics Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Mortise Medical, LLC
- Decided: Sep 19, 2017 after 81 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: 6 generations back to K971723 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 5.
- K113274: Footprint Ultra PK Suture Anchor, Smith & Nephew, Inc. (2012) Summary page 5.
- K123579: Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL, Smith & Nephew, Inc. (2013) Summary page 5.
- K133229: Titanium Suture Anchor, Mtp Solutions, LLC (2014) Summary page 5.

## Indications for use
The LigaMetrics Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair. Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction. Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction. Hip: Distal row abductor tendon repair

Source page: https://510kreport.com/device/K171964
Methodology: https://510kreport.com/methodology