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

Dyonics, Inc. — Predicate Candidate Screening

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

51 daysmedian FDA review time
233 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEMDyonics, Inc.1990-02-16430
K896416DYONICS SHOULDER PORTAL SYSTEMDyonics, Inc.1990-01-02550
K893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTYDyonics, Inc.1989-12-142330
K890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIESDyonics, Inc.1989-11-032670
K894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFEDyonics, Inc.1989-08-18230
K892062PS3500 ARTHROSCOPIC SURGICAL SYSTEMDyonics, Inc.1989-06-23850
K884839MODIFIED SAW BLADES TO THE SAGITAL SAWDyonics, Inc.1988-12-07160
K881876DYNAMIC CRUCIATE TESTERDyonics, Inc.1988-11-171970
K880739DYONICS DRILL GUIDE/ISOMETER SYSTEMDyonics, Inc.1988-03-21260
K880150PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEMDyonics, Inc.1988-03-04510
K870212ARTHROSCOPIC SHOULDER HOLDERDyonics, Inc.1987-02-20310
K862017ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KITDyonics, Inc.1986-12-152010
K843121GUIDE TO THE KNEEDyonics, Inc.1984-09-07300
K833943MENISCAL SUTURING SYSTEMDyonics, Inc.1984-02-271040
K833587DISPOSABLE ARTHROSCOPY BLADEDyonics, Inc.1983-11-14330
K820367INTRA-ARTICULAR SURGICAL SYSTEMDyonics, Inc.1982-05-07870
K812506THE ARTHROFILEDyonics, Inc.1981-09-24230
K790502DYONICS STEROTOXIC POSITIONERDyonics, Inc.1979-04-05230
K771218INTRA-ARTICULAR SHAVERDyonics, Inc.1978-02-012110

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