Atlas FDA

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

Orthopaedic Implant Company · Predicate Candidate Screening

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

117 daysmedian FDA review time
231 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024-02-02920
K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company2023-02-13600
K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company2023-01-211100
K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company2022-04-052310
K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company2021-05-062180
K211112OIC External Fixation SystemOrthopaedic Implant Company2021-05-05210
K183682OIC External Fixation SystemOrthopaedic Implant Company2019-04-081010
K171211OIC External Fixation SystemOrthopaedic Implant Company2017-09-271550
K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company2015-07-091180
K140357OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEMOrthopaedic Implant Company2014-06-091170

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