# K972023: Sleep-in Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Aug 25, 1997 after 84 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- 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 K920213 (1992). 9 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970292: IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw, Influence, Inc. (1997) Summary page 1.
- K920213: Mitek Anchor, Mitek Anchor II, Mitek Surgical Products, Inc. (1992) Summary page 1.
- K953293: PM Positioner, Jonathan A. Parker, D.D.S. (1995) Summary page 1.
- K955503: Adjustable PM Positioner, Jonathan A. Parker, D.D.S. (1996) Summary page 1.
- K954324: Snor-X Mouth Guard, Snorex, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K932925: Bone Anchor for Soft Tissue Attachment, Vesitec Medical, Inc. (1994). Our OCR of the scanned summary read K932925, FDA’s number for Bone Anchor for Soft Tissue Attachment (Vesitec Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Protecta-Pass™ Suture Passer”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K981677: Repose Bone Screw System (1999), 16 descendants of its own
- K101060: Siesta Medical, Inc., Prelude Tongue Suspension System (2010), 15 descendants of its own
- K103179: Prelude II Tounge Suspension System (2010), 14 descendants of its own
- K110127: Prelude Iii Tongue Suspension System (2011), 13 descendants of its own
- K111179: Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue Suspension System System (Monofilamen (2011), 6 descendants of its own

## Indications for use
The Sleep-In™ Bone Screw System is intended for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

Source page: https://510kreport.com/device/K972023
Methodology: https://510kreport.com/methodology