Skeletal Kinetics, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Skeletal Kinetics, LLC” (first 2003, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 97 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 173 |
| 2013 | 1 | 409 |
| 2014 | 1 | 384 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 92 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Skeletal Kinetics, LLC took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 6 | 6 |
| GXP | Methyl Methacrylate For Cranioplasty | 3 | 3 |
| MTJ | Wax, Bone | 1 | 1 |
Review panels
- Orthopedic (7)
- Neurology (3)
Most recent Skeletal Kinetics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162864 | OsteoVation Impact | GXP | 2017-01-13 | 92 |
| K132211 | SKAFFOLD NMX BONE VOID FILLER | MQV | 2014-08-04 | 384 |
| K120354 | BETA-TCP GRANULES | MQV | 2013-03-21 | 409 |
| K112383 | CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER | MQV | 2012-02-07 | 173 |
| K111538 | SKAFFOLD CIS | MTJ | 2011-10-25 | 145 |
| K100986 | CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION | MQV | 2010-07-20 | 102 |
| K051784 | OSTEOVATION CMF BONE VOID FILLER | GXP | 2005-07-20 | 19 |
| K051123 | CALLOS IMPACT AND INJECT BONE VOID FILLER | MQV | 2005-06-03 | 31 |
| K042072 | CALLOS CMF BONE VOID FILLER | GXP | 2004-09-16 | 45 |
| K030554 | CALLOS | MQV | 2003-05-20 | 88 |
Recalls
49 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2020-04-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Skeletal Dynamics, Inc. (40 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Skeletal Kinetics, LLC?
FDA lists 10 510(k) clearances under the applicant name “Skeletal Kinetics, LLC” (first 2003, latest 2017), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Skeletal Kinetics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Skeletal Kinetics, LLC is 97 days.
Which FDA product codes appear under Skeletal Kinetics, LLC?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 6); GXP (Methyl Methacrylate For Cranioplasty, 3); MTJ (Wax, Bone, 1).
Next steps
- See all 10 Skeletal Kinetics, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQV, Skeletal Kinetics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.