# Core Essence Orthopaedics, LLC

- Location (FDA's records): Yardley, PA
- FDA decisions: 6 (2007–2011): 6 510(k) clearances
- Names in FDA's records: Core Essence Orthopaedics, LLC (3); Core Essence Orthopaedics, Inc. (2); Core Essence Orthopaedics (1)
- Product codes: MBI (3), JDR (1), GAT (1), GAQ (1)
- Predicates its devices cite: 26 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mitek Products: 4 (https://510kreport.com/company/mitek-products)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Biomedical Ent., Inc.: 2 (https://510kreport.com/company/biomedical-ent)
- Intelifuse, Inc.: 2 (https://510kreport.com/company/intelifuse)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Pontis Orthopaedics, LLC: 3 (https://510kreport.com/company/pontis-orthopaedics)
- Ot Medical GmbH: 1 (https://510kreport.com/company/ot-medical)
- Fusion Orthopedics, LLC: 1 (https://510kreport.com/company/fusion-orthopedics)
- Pontis Orthopaeeics, LLC: 1 (https://510kreport.com/company/pontis-orthopaeeics)

## Its most-cited devices
- K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X (2007), cited by 3
- K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5 (2008), cited by 3
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps (2010), cited by 2
- K071477: Reverto 55 and 37 Shape Memory Staples (2007), cited by 1
- K090128: Tac-Tite (TM) (2009), cited by 1

## Recent decisions
- K111716: Knotless Suture Fixation System (Nov 10, 2011)
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps (Dec 2, 2010)
- K090128: Tac-Tite (TM) (Mar 19, 2009)
- K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5 (Dec 24, 2008)
- K071477: Reverto 55 and 37 Shape Memory Staples (Aug 15, 2007)
- K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X (Aug 10, 2007)

Source page: https://510kreport.com/company/core-essence-orthopaedics