Skeletal Dynamics, Inc.: FDA clearances and approvals
Skeletal Dynamics, Inc. has 40 FDA 510(k) clearances (first 2010, latest 2026), across 11 product codes in 2 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 84 days, against 99 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Skeletal Dynamics, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 27 |
| 2013 | 1 | 170 |
| 2014 | 2 | 97 |
| 2015 | 3 | 56 |
| 2016 | 0 | — |
| 2017 | 2 | 67 |
| 2018 | 2 | 24 |
| 2019 | 0 | — |
| 2020 | 5 | 90 |
| 2021 | 1 | 143 |
| 2022 | 2 | 44 |
| 2023 | 5 | 155 |
| 2024 | 6 | 92 |
| 2025 | 1 | 58 |
| 2026 | 2 | 72 |
Review time against the same product codes
Since 2017, Skeletal Dynamics, Inc.'s cleared 510(k)s took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 19 | 19 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 3 | 3 |
| OZI | Internal Hinged Elbow Fixator | 3 | 3 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 2 | 2 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (39)
- General Hospital (1)
Most recent Skeletal Dynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261770 | Suture Button Repair System | MBI | 2026-07-29 | 61 |
| K254288 | Clavicle Fixation System | HRS | 2026-03-23 | 82 |
| K252949 | Geminus Volar Distal Radius Plating System | HRS | 2025-11-13 | 58 |
| K242436 | Proximal Humerus Fixation System | HRS | 2024-11-14 | 90 |
| K243381 | Total Wrist Arthroplasty System (TWA) | JWJ | 2024-11-01 | 2 |
| K241815 | Protean Fragment Plating System | HRS | 2024-09-26 | 94 |
| K242055 | Freefix Forearm Plating System | HRS | 2024-08-01 | 17 |
| K240835 | Suture Button Repair System | MBI | 2024-07-19 | 115 |
| K233574 | Total Wrist Arthroplasty System (TWA) | JWJ | 2024-07-03 | 239 |
| K231447 | Double Internal Joint Stabilizer- Elbow | OZI | 2023-12-15 | 211 |
30 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-10-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Skeletal Dynamics, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01944670: Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow (Completed, started 2013-08)
Frequently asked questions
How many FDA 510(k) clearances does Skeletal Dynamics, Inc. have?
Skeletal Dynamics, Inc. has 40 FDA 510(k) clearances (first 2010, latest 2026), across 11 product codes in 2 review panels.
How long does FDA take to clear Skeletal Dynamics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Skeletal Dynamics, Inc.'s cleared 510(k)s is 88 days. Since 2017: 84 days, versus 99 days for all cleared 510(k)s in the same product codes.
What devices does Skeletal Dynamics, Inc. make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 19); HWC (Screw, Fixation, Bone, 5); KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer, 3).
Has Skeletal Dynamics, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Skeletal Dynamics, Inc; the most recent began 2014-10-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 40 Skeletal Dynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Skeletal Dynamics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.