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

Kinetikos Medical, Inc. · Predicate Candidate Screening

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

76 daysmedian FDA review time
220 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061749ECLIPSE TOTAL ANKLE IMPLANTKinetikos Medical, Inc.2006-11-221540
K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.2006-10-051320
K051611MBARESORB IMPLANTKinetikos Medical, Inc.2005-09-06810
K041461KMI DISTAL VOLAR RADIUS PLATE SYSTEMKinetikos Medical, Inc.2004-08-16750
K032806KATALYST RADIAL HEAD IMPLANTKinetikos Medical, Inc.2004-04-162200
K040356KOMPRESSOR SCREW SYSTEMKinetikos Medical, Inc.2004-03-01170
K024233KOMPRESSOR SCREW SYSTEMKinetikos Medical, Inc.2003-02-06450
K030037UNIVERSAL TOTAL WRIST SYSTEMKinetikos Medical, Inc.2003-02-05300
K023770K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANTKinetikos Medical, Inc.2002-12-12300
K020554MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEMKinetikos Medical, Inc.2002-05-03720
K991873KMI WRIST FUSION SYSTEMKinetikos Medical, Inc.1999-08-17760
K990094KMI WRIST FUSION SYSTEMKinetikos Medical, Inc.1999-02-18370
K960539DIAO HAND SURGERY SETKinetikos Medical, Inc.1996-07-231670
K960692SUBTALAR MBA SYSTEMKinetikos Medical, Inc.1996-07-231540
K961051UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)Kinetikos Medical, Inc.1996-06-06870
K960537K2 BONE SCREW SYSTEMKinetikos Medical, Inc.1996-03-25470
K960533K3 BONE SCREW SYSTEMKinetikos Medical, Inc.1996-03-25470
K950704K4 BONE SCREW SYSTEMKinetikos Medical, Inc.1995-06-301350
K924724KINETIK GREAT TOE SYSTEMKinetikos Medical, Inc.1994-01-054710

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