# K261008: Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Apr 24, 2026 after 29 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: 10 generations back to K960978 (1996). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242280: Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips, Stryker Spine (2024) Summary page 7.

## Indications for use
These implants are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These implants are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. These implants should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. These implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes intervertebral disc space and posterolateral fusion procedures). When used in intervertebral body fusion procedures with an intervertebral body fusion device cleared by FDA for use with a bone void filler, Vitoss® can be mixed with saline, autogenous blood, bone marrow, and/or used on its own. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. The Vitoss® Foam family of products may be mixed with saline in addition to autogenous blood or bone marrow. The Vitoss® Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This canister provides the surgeon with a convenient way to mix autogenous blood with Vitoss® and deliver the material to the orthopaedic surgical site. Vitoss® Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss® Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes intervertebral disc space and posterolateral fusion procedures) and may be combined with saline, autogenous blood, and/or bone marrow. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients 6 years old), are surgically created or the result of traumatic injury to the bone. When used in intervertebral body fusion procedures with an intervertebral body fusion device cleared by FDA for use with a bone void filler, Vitoss® can be mixed with saline, autogenous blood, bone marrow, and/or used on its own. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. These implants are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients 6 years old), are surgically created or the result of traumatic injury to the bone. When used in intervertebral body fusion procedures with an intervertebral body fusion device cleared by FDA for use with a bone void filler, Vitoss® can be mixed with saline, autogenous blood, bone marrow, and/or used on its own. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K261008
Methodology: https://510kreport.com/methodology