# Innovasive Devices, Inc.

- Location (FDA's records): Marlboro, MA
- FDA decisions: 34 (1993–2000): 34 510(k) clearances
- Product codes: MBI (22), MAI (4), HWC (3), JDR (2), GCJ (1), OCW (1), HRX (1)
- Predicates its devices cite: 16 (12 its own); citations of its devices by later devices: 38 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Mitek Surgical Products, Inc.: 1 (https://510kreport.com/company/mitek-surgical-products)
- Acufex Microsurgical, Inc.: 1 (https://510kreport.com/company/acufex-microsurgical)
- Medicinelodge, Inc.: 1 (https://510kreport.com/company/medicinelodge)

## Firms that cite its devices most
- Bionx Implants, Inc.: 6 (https://510kreport.com/company/bionx-implants)
- Orthopaedic Biosystems, Ltd.: 3 (https://510kreport.com/company/orthopaedic-biosystems)
- Mitek Products: 2 (https://510kreport.com/company/mitek-products)
- Johnson & Johnson: 2 (https://510kreport.com/company/johnson-johnson)
- Biomet Sports Medicine: 1 (https://510kreport.com/company/biomet-sports-medicine)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Depuy Mitek, A Johnson & Johnson Company: 1 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Inion, Ltd.: 1 (https://510kreport.com/company/inion)

## Its most-cited devices
- K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener (1999), cited by 7
- K970316: Innovasive 8MM Ligament Fastener (1997), cited by 4
- K963402: Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener (1996), cited by 4
- K984490: Sutureless Anchor (1999), cited by 3
- K973381: Bioroc EZ Suture Bone Fastener (1998), cited by 3
- K971922: Innovasive 2.8MM and 3.5MM Roc EZ Suture Bone Fastener (1997), cited by 3

## Recent decisions
- K994269: Titan RC Tack (Jan 10, 2000)
- K993975: Absolute Absorbable Interference Screw (Dec 20, 1999)
- K992458: RC Multisuture Bone Anchor, Model 4453/4454 (Oct 14, 1999)
- K992377: RC Tack (Oct 8, 1999)
- K990454: Bio-Interference Screw (Jul 1, 1999)
- K984490: Sutureless Anchor (Mar 1, 1999)
- K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener (Jan 28, 1999)
- K983056: Innovasive Tibial Fastener (Oct 13, 1998)

Source page: https://510kreport.com/company/innovasive-devices