# K040537: Ams Apogee Vault Suspension System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Apr 22, 2004 after 51 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931386 (1993). 20 ancestors in all.
70 later devices descend from it; 5 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K013355: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K020663: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K030123: Bioarc SP Sling Kit, American Medical Systems, Inc. (2003) Summary page 1.
- K033636: Ams Large Pore Polypropylene Mesh, American Medical Systems, Inc. (2003) Summary page 1.
- K010035: Ivs Tunneller, United States Surgical, A Division of Tyco Healthc (2001)

## Most influential descendants
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems (2008), 20 descendants of its own
- K051485: Ams Pelvic Floor Repair System (2005), 17 descendants of its own
- K092207: Restorelle Polypropylene Mesh (2009), 13 descendants of its own
- K073219: WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6 CM X 8 CM, Model 89XM-6X08 (2008), 12 descendants of its own

## Indications for use
The Apogee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

Source page: https://510kreport.com/device/K040537
Methodology: https://510kreport.com/methodology