# K112965: Nano Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corporation D/B/A Conmed Linvatec
- Decided: Nov 2, 2011 after 28 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K911837 (1991). 75 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091549: Conmed Linvatec Soft Tissue to Bone System, Linvatec Corp. (2009) Summary page 1.
- K090835: Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR, Linvatec Corp. (2009) Summary page 1.

## Most influential descendants
- K180951: Responsive Arthroscopy Suture Anchor System (2019), 4 descendants of its own
- K181076: Responsive Arthroscopy Wedge Push-In Suture Anchors (2019), 2 descendants of its own
- K222763: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (2022), 1 descendant of its own
- K202153: Responsive Arthroscopy Suture Anchor System (2020), 1 descendant of its own
- K190446: Responsive Arthroscopy Wedge Push-In Suture Anchors (2019), 1 descendant of its own

## Recalls of this device
- Jun 26, 2012 · Class II · Z-0065-2013: Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip
- Jun 26, 2012 · Class II · Z-0068-2013: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of t
- Jun 26, 2012 · Class II · Z-0063-2013: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of t
- Jun 26, 2012 · Class II · Z-0067-2013: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of t
- Jun 26, 2012 · Class II · Z-0064-2013: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of t
- Jun 26, 2012 · Class II · Z-0066-2013: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of t

## Indications for use
The NANOTM Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint, capsules to the bone, The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular Ilabral repair and capsular repair in the hip.

Source page: https://510kreport.com/device/K112965
Methodology: https://510kreport.com/methodology