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

Innovasive Devices, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
196 days90th percentile
34clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994269TITAN RC TACKInnovasive Devices, Inc.2000-01-10210
K993975ABSOLUTE ABSORBABLE INTERFERENCE SCREWInnovasive Devices, Inc.1999-12-20260
K992458RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454Innovasive Devices, Inc.1999-10-14830
K992377RC TACKInnovasive Devices, Inc.1999-10-08850
K990454BIO-INTERFERENCE SCREWInnovasive Devices, Inc.1999-07-011390
K984490SUTURELESS ANCHORInnovasive Devices, Inc.1999-03-01740
K983560INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENERInnovasive Devices, Inc.1999-01-281070
K983056INNOVASIVE TIBIAL FASTENERInnovasive Devices, Inc.1998-10-13420
K981340INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEMInnovasive Devices, Inc.1998-06-22700
K981193INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENERInnovasive Devices, Inc.1998-06-16750
K980491INNOVASIVE LINX TIBIAL LIGAMENT FASTENERInnovasive Devices, Inc.1998-04-29790
K980681INNOVASIVE DEVICES MENISCAL SCREWInnovasive Devices, Inc.1998-04-29680
K980334INNOVASIVE 10MM LINX HT LIGAMENT FASTENERInnovasive Devices, Inc.1998-04-27890
K973874ACL CLIP-IN PLATEInnovasive Devices, Inc.1998-04-241960
K973381BIOROC EZ SUTURE BONE FASTENERInnovasive Devices, Inc.1998-02-181630
K974049INNOVASIVE LINX BT 10MM LIGAMENT FASTENERInnovasive Devices, Inc.1998-02-181170
K973323ACL CLIP-INInnovasive Devices, Inc.1997-12-01880
K973313INNOVASIVE DEVICES Y-KNOT SUTURE CLIPInnovasive Devices, Inc.1997-12-01890
K972438INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENERInnovasive Devices, Inc.1997-09-26880
K972356INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENERInnovasive Devices, Inc.1997-08-26620
K971922INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENERInnovasive Devices, Inc.1997-08-07760
K970423INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICEInnovasive Devices, Inc.1997-04-30850
K970316INNOVASIVE 8MM LIGAMENT FASTENERInnovasive Devices, Inc.1997-04-16820
K970089INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENERInnovasive Devices, Inc.1997-03-25740
K964945INNOVASIVE DEVICES ROTATOR CUFF FASTNERInnovasive Devices, Inc.1997-02-24760
K963402INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTUInnovasive Devices, Inc.1996-11-04670
K954338INNOVASIVE 1.9MM ROC SUTURE BONE FASTENERInnovasive Devices, Inc.1996-03-211850
K952237INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENERInnovasive Devices, Inc.1995-12-082100
K951565INNOVASIVE DEVICES ROTATOR CUFF FASTENERInnovasive Devices, Inc.1995-09-081570
K944831INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENInnovasive Devices, Inc.1995-02-011250
K935321INNOVASIVE SUTURE BONE FASTENER WITH SUTUREInnovasive Devices, Inc.1994-10-193490
K941273INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENERInnovasive Devices, Inc.1994-09-161840
K934338INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATIONInnovasive Devices, Inc.1994-02-101560
K924034MINVASIVE SUTURE BONE FASTENERInnovasive Devices, Inc.1993-08-243780

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