# K981677: Repose Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Aug 27, 1999 after 472 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K920213 (1992). 10 ancestors in all.
16 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)
- K972023: Sleep-in Bone Screw System, Influence, Inc. (1997) Summary page 2.
- K970292: IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw, Influence, Inc. (1997) Summary page 2.
- K920213: Mitek Anchor, Mitek Anchor II, Mitek Surgical Products, Inc. (1992) Summary page 2.

## Most influential descendants
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K122391: Medtronic Xomed, Inc. (2013), 4 descendants of its own
- K011723: Anti-Snoring Device or Asd (2002), 4 descendants of its own
- K133680: Encore System (2014), 3 descendants of its own
- K122130: Winx Sleep Therapy System (2012), 3 descendants of its own

## Recalls of this device
- Jul 27, 2009 · Not classified · Z-0535-2010: Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw
- Jul 27, 2009 · Not classified · Z-0536-2010: Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw

## Indications for use
The Repose™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid suspension procedure as an adjunct to tongue base suspension. It is indicated for the treatment of obstructive sleep apnea (“OSA”) and/or snoring.

Source page: https://510kreport.com/device/K981677
Methodology: https://510kreport.com/methodology