Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Restor3D — Predicate Candidate Screening

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

95 daysmedian FDA review time
174 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260556Veritas Shoulder SystemRestor3D2026-07-011320
K253992Veritas Reverse Total Shoulder SystemRestor3D2026-05-071460
K252454Kinos Total Ankle SystemRestor3D2025-09-03300
K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D2025-05-191740
K242868Kinos Total Ankle SystemRestor3D2024-10-18280
K241482Kinos Total Ankle SystemRestor3D2024-07-22590
K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D2024-01-22310
K232595Kinos Axiom Total Ankle SystemRestor3D2023-11-28950
K231458Extremity StapleRestor3D2023-08-03760
K223326Axiom PSR SystemRestor3D2023-03-301500
K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D2022-06-171140
K211789restor3d Pin ImplantsRestor3D2022-01-042080
K193491restor3d Metallic Interference ScrewRestor3D2020-03-19930

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