# K071281: Uniring - Annuloplasty Ring with Sizers

- Pathway: 510(k) (Traditional)
- Applicant: Peters Surgical
- Decided: Aug 3, 2007 after 88 days
- Product code: KRH (Ring, Annuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923367 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033685: Northrup Universal Annuloplasty System, Model 1000, Medical Cv, Inc. (2004) Summary page 2.
- K992056: Annuloflex Annuloplasty System, Model AF800, Sulzer Carbomedics, Inc. (1999) Summary page 2.
- K923367: Cosgrove Edwards Annuloplasty System, Model 4600, Baxter Healthcare Corp (1993) Summary page 2.
- K926138: Carpentier-Edwards Physio Annuloplasty Ring, Baxter Healthcare Corp (1993) Summary page 2.

## Indications for use
The UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Source page: https://510kreport.com/device/K071281
Methodology: https://510kreport.com/methodology