# K253147: FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Prosidyan, Inc.
- Decided: Oct 22, 2025 after 27 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). 379 ancestors in all.
No later device cites it as a predicate yet.
1 of 380 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty, Depuy Spine (2022) Summary page 8.
- K213803: FIBERGRAFT Aeridyan Matrix Bone Graft Substitute, Prosidyan, Inc. (2022) Summary page 8.
- K180080: FIBERGRAFT BG Matrix Bone Graft Substitute, Prosidyan, Inc. (2018) Summary page 8.

## Indications for use
FIBERGRAFT™ BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. FIBERGRAFT™ AERIDYAN™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ AERIDYAN™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities and pelvis). 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ AERIDYAN™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT™ AERIDYAN™ Matrix must be hydrated with saline or blood for pelvis and extremity applications. FIBERGRAFT™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Source page: https://510kreport.com/device/K253147
Methodology: https://510kreport.com/methodology