Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skeletal Dynamics, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
155 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 | 61 | 0 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 | 82 | 0 |
| K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | 2025-11-13 | 58 | 0 |
| K242436 | Proximal Humerus Fixation System | Skeletal Dynamics, Inc. | 2024-11-14 | 90 | 0 |
| K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | 2024-11-01 | 2 | 0 |
| K241815 | Protean Fragment Plating System | Skeletal Dynamics, Inc. | 2024-09-26 | 94 | 0 |
| K242055 | Freefix Forearm Plating System | Skeletal Dynamics, Inc. | 2024-08-01 | 17 | 0 |
| K240835 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2024-07-19 | 115 | 0 |
| K231447 | Double Internal Joint Stabilizer- Elbow | Skeletal Dynamics, Inc. | 2023-12-15 | 211 | 0 |
| K231188 | ALIGN Radial Head System | Skeletal Dynamics, Inc. | 2023-09-28 | 155 | 0 |
| K231623 | Distal Elbow Plating System | Skeletal Dynamics, Inc. | 2023-08-28 | 87 | 0 |
| K223318 | Internal Joint Stabilizer - Elbow | Skeletal Dynamics, Inc. | 2023-05-10 | 194 | 0 |
| K230908 | Hand Trauma Threaded Nail System | Skeletal Dynamics, Inc. | 2023-04-28 | 28 | 0 |
| K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc. | 2022-05-12 | 59 | 0 |
| K213895 | Distal Humerus Plating System | Skeletal Dynamics, Inc. | 2022-01-13 | 30 | 0 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 | 143 | 0 |
| K201962 | Skeletal Dynamics Ulnar Shortening Plating System | Skeletal Dynamics, Inc. | 2020-10-13 | 90 | 0 |
| K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. | 2020-07-16 | 27 | 0 |
| K200538 | Skeletal Dynamics Forearm Plating System | Skeletal Dynamics, Inc. | 2020-06-01 | 90 | 0 |
| K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. | 2020-05-14 | 57 | 0 |
| K200367 | Distal Humerus Plating System | Skeletal Dynamics, Inc. | 2020-05-14 | 90 | 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