Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Bone Solutions, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
773 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2025-10-13 | 150 | 0 |
| K242372 | Mg OSTEOREVIVE™, Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2024-10-18 | 70 | 0 |
| K234013 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2024-02-05 | 48 | 0 |
| K221256 | Mg OSTEOINJECT | Bone Solutions, Inc. | 2022-06-28 | 57 | 0 |
| K212991 | Osteorevive | Bone Solutions, Inc. | 2022-01-21 | 123 | 0 |
| K192674 | Mixing and Delivery System | Bone Solutions, Inc. | 2020-02-18 | 145 | 0 |
| K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016-09-16 | 101 | 0 |
| K071004 | OSTEOCRETE BONE VOID FILLER | Bone Solutions, Inc. | 2009-05-21 | 773 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda