# K141711: Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis Ultra-High Molecular Weight Polye

- Pathway: 510(k) (Special)
- Applicant: Pontis Orthopaeeics, LLC
- Decided: Jul 24, 2014 after 29 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: 5 generations back to K961555 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps, Core Essence Orthopaedics, Inc. (2010) Summary page 1.

## Indications for use
The PONTISTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures are indicated to secure soft tissue to soft tissue reattachment in the hand: Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons The PONTiSTM 3mm Noriabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to bone reattachmient in the hand: Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons

Source page: https://510kreport.com/device/K141711
Methodology: https://510kreport.com/methodology