# K243706: Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jan 17, 2025 after 49 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: 26 generations back to K841189 (1984). 373 ancestors in all.
No later device cites it as a predicate yet.
1 of 374 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 6.
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty, Depuy Spine (2022) Summary page 6.

## Indications for use
Mastergraft™ Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Matrix EXT must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mastergraft™ Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Strip must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mastergraft™ Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps not intrinsic to the stability of the bony structure. Additionally, Mastergraft™ Putty can be used with autograft as a bone graft extender. Mastergraft™ Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, intervertebral disc space, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Mastergraft™ Putty resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mastergraft™ Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, Mastergraft™ Granules can be used with autograft as a bone graft extender. Mastergraft™ Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, intervertebral disc space, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Mastergraft™ Granules provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Granules must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Source page: https://510kreport.com/device/K243706
Methodology: https://510kreport.com/methodology