Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Skeletal Dynamics, LLC — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
333 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC2018-10-10290
K180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLC2018-04-11200
K172688Align Radial Head SystemSkeletal Dynamics, LLC2017-12-221070
K171590Distal Elbow Plating SystemSkeletal Dynamics, LLC2017-06-27270
K153208Internal Joint Stabilizer - ElbowSkeletal Dynamics, LLC2015-12-31560
K150675Dorsal Spanning PlateSkeletal Dynamics, LLC2015-05-12570
K143624Headless Compression Screw SystemSkeletal Dynamics, LLC2015-01-13220
K140892DISTAL ELBOW PLATING SYSTEMSkeletal Dynamics, LLC2014-08-281420
K140372FRAGMENT PLATE SYSTEMSkeletal Dynamics, LLC2014-04-07520
K122310GEMINUS FOSSA SPECIFIC PLATE SYSTEMSkeletal Dynamics, LLC2013-01-181700
K122737GEMINUS FOSSA SPECIFIC PLATE SYSTEMSkeletal Dynamics, LLC2012-10-03270
K111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, ANDSkeletal Dynamics, LLC2011-12-302560
K112672HEADLESS COMPRESSION SCREWSkeletal Dynamics, LLC2011-12-13900
K111620SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STSkeletal Dynamics, LLC2011-08-23740
K102103SKELETAL DYNAMICS STERILIZATION TRAYSSkeletal Dynamics, LLC2010-12-071330
K092723AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEMSkeletal Dynamics, LLC2010-10-043950
K092721ALIGN RADIAL HEAD SYSTEMSkeletal Dynamics, LLC2010-08-033331
K092720WRIST ARTHRODESIS NAIL SYSTEMSkeletal Dynamics, LLC2010-06-292980

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