# K230486: Cove Strip

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Aug 21, 2023 after 179 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K960978 (1996). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140375: Mastergraft Putty, Mastergraft Strip, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K063124: Integra Mozaik Bone Regeneration Matrix - Strips, Integra Lifesciences Corp. (2007) Summary page 4.

## Most influential descendants
- K232668: Cove Strip, OsteoCove Strip (2023), 0 descendants of its own

## Indications for use
Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during the healing process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

Source page: https://510kreport.com/device/K230486
Methodology: https://510kreport.com/methodology