Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skeletal Kinetics, LLC — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
409 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | 2017-01-13 | 92 | 0 |
| K132211 | SKAFFOLD NMX BONE VOID FILLER | Skeletal Kinetics, LLC | 2014-08-04 | 384 | 0 |
| K120354 | BETA-TCP GRANULES | Skeletal Kinetics, LLC | 2013-03-21 | 409 | 0 |
| K112383 | CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) | Skeletal Kinetics, LLC | 2012-02-07 | 173 | 0 |
| K111538 | SKAFFOLD CIS | Skeletal Kinetics, LLC | 2011-10-25 | 145 | 0 |
| K100986 | CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID | Skeletal Kinetics, LLC | 2010-07-20 | 102 | 2 |
| K051784 | OSTEOVATION CMF BONE VOID FILLER | Skeletal Kinetics, LLC | 2005-07-20 | 19 | 5 |
| K051123 | CALLOS IMPACT AND INJECT BONE VOID FILLER | Skeletal Kinetics, LLC | 2005-06-03 | 31 | 6 |
| K042072 | CALLOS CMF BONE VOID FILLER | Skeletal Kinetics, LLC | 2004-09-16 | 45 | 0 |
| K030554 | CALLOS | Skeletal Kinetics, LLC | 2003-05-20 | 88 | 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