# K101126: Pontis Sutures and Suture Anchors with Optional Crimps

- Pathway: 510(k) (Traditional)
- Applicant: Core Essence Orthopaedics, Inc.
- Decided: Dec 2, 2010 after 224 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: 4 generations back to K961555 (1996). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5, Core Essence Orthopaedics, LLC (2008) Summary page 2.
- K992616: SDB Cerclage System, Pioneer Surgical Technology (1999) Summary page 2.
- K023594: Teno Fix, Ortheon Medical, LLC (2003) Summary page 2.
- K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X, Core Essence Orthopaedics, LLC (2007) Summary page 2.
- K962511: Mitek Micro Anchor, Mitek Products (1996) Summary page 2.

## Most influential descendants
- K140127: Ferrofibre Stainless Steel Suture with Crimp (2014), 1 descendant of its own
- K143582: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel (2015), 0 descendants of its own
- K141711: Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis Ultra-High Molecular Weight Polye (2014), 0 descendants of its own

## Indications for use
PONTiSTM Sutures with Optional Crimps 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 PONTiSrM Suture Anchors with Optional Crimps are indicated to secure soft tissue to bone reattachment in the hand: " Collateral Ligaments around the PIP, DIP and MCP Joints * Flexor and Extensor Tendons

Source page: https://510kreport.com/device/K101126
Methodology: https://510kreport.com/methodology