# K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X

- Pathway: 510(k) (Traditional)
- Applicant: Core Essence Orthopaedics, LLC
- Decided: Aug 10, 2007 after 67 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: 3 generations back to K961555 (1996). 19 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962511: Mitek Micro Anchor, Mitek Products (1996) Summary page 3.
- K962793: Mitek Micro Anchor, Mitek Products (1996) Summary page 3.
- K982420: Mitek Micro Anchor, Mitek Products (1998) Summary page 3.
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) Summary page 3.
- K962397: Statak Soft Tissue Attachment Device, Zimmer, Inc. (1996) Summary page 3.
- K012503: Metal Screw Anchor, Biomet Manufacturing, Inc. (2001) Summary page 3.
- K973775: Harpoon Suture Anchors, Biomet, Inc. (1998) Summary page 3.
- K943806: Harpoon Suture Anchors, Biomet, Inc. (1995) Summary page 3.
- K971723: Fastak Suture Anchor (11.7MM)/(7.5MM), Arthrex, Inc. (1997) Summary page 3.
- K960516: Fastak Suture Anchor, Arthrex, Inc. (1996) Summary page 3.
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 3.
- K972326: Peba Anchor/Suture Combination, Orthopaedic Biosystems, Ltd. (1998) Summary page 3.
- K040594: Herculon Soft Tissue Reattachment System, United States Surgical, A Division of Tyco Healthc (2004) Summary page 3.

## Most influential descendants
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps (2010), 3 descendants of its own
- K140127: Ferrofibre Stainless Steel Suture with Crimp (2014), 1 descendant of its own
- K090128: Tac-Tite (TM) (2009), 1 descendant of its own
- K193377: TopLock Anchor System (2020), 0 descendants of its own
- K143582: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel (2015), 0 descendants of its own

## Indications for use
reNOVO Suture Anchors are intended to secure soft tissue to bone of: The Shoulder: Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

Source page: https://510kreport.com/device/K071520
Methodology: https://510kreport.com/methodology