# Integra LifeSciences Corporation

- Location (FDA's records): Planisboro, NJ
- FDA decisions: 101 (1981–2025): 94 510(k) clearances and 7 original PMA approvals
- Names in FDA's records: Integra LifeSciences Corporation (69); Integra Lifesciences Corp. (32)
- Product codes: JXG (14), LFL (13), HBL (10), GWM (8), KGN (7), GXQ (6), HRS (5), JXI (4), PHX (4), MQV (3), NQR (2), LMF (2)
- 510(k) review time since 2016: median 105 days, against 133 for FDA's reviews in the same codes and years (15 of 26 faster)
- Predicates its devices cite: 164 (47 its own); citations of its devices by later devices: 167 (47 its own)
- Recalls linked to its devices: 130 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Integra Neurosciences: 8 (https://510kreport.com/company/integra-neurosciences)
- Integra Neurosciences Implants S.A.: 6 (https://510kreport.com/company/integra-neurosciences-implants)
- Cordis Corp.: 6 (https://510kreport.com/company/cordis)
- Newdeal Sas: 5 (https://510kreport.com/company/newdeal)
- Integra Neurocare, LLC: 4 (https://510kreport.com/company/integra-neurocare)
- Ascension Orthopedics, Inc.: 4 (https://510kreport.com/company/ascension-orthopedics)
- Heyer Schulte Corp.: 3 (https://510kreport.com/company/heyer-schulte)
- Ohio Medical Instrument Co., Inc.: 3 (https://510kreport.com/company/ohio-medical-instrument)

## Firms that cite its devices most
- Collagen Matrix, Inc.: 6 (https://510kreport.com/company/collagen-matrix)
- Smith & Nephew, Inc.: 4 (https://510kreport.com/company/smith-nephew)
- Collamatrix Co., Inc.: 3 (https://510kreport.com/company/collamatrix)
- W. L. Gore & Associates, Inc.: 3 (https://510kreport.com/company/w-l-gore-associates)
- Gunze Limited: 3 (https://510kreport.com/company/gunze)
- Waldemar Link GmbH & Co. KG: 3 (https://510kreport.com/company/waldemar-link)
- Imris, Inc.: 3 (https://510kreport.com/company/imris)
- Cook Biotech, Inc.: 3 (https://510kreport.com/company/cook-biotech)

## Its most-cited devices
- K022127: Avagen Wound Dressing (2002), cited by 10
- K011168: Neurogen Nerve Guide (2001), cited by 9
- K021792: Bilayer Matrix Wound Dressing (2002), cited by 9
- K003229: Biopatch Antimicrobial Dressing (2001), cited by 8
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram (1999), cited by 8
- K053655: Tendon Wrap Tendon Protector (2006), cited by 7

## Recent decisions
- K251162: CUSA® Clarity Ultrasonic Surgical Aspirator System (Oct 8, 2025)
- K250752: AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (Apr 9, 2025)
- K240493: CUSA® Clarity Ultrasonic Surgical Aspirator System (Jul 11, 2024)
- K230427: CUSA Clarity Ultrasonic Surgical Aspirator System (Jul 11, 2023)
- K221835: CUSA Clarity Ultrasonic Surgical Aspirator System (Aug 22, 2022)
- K221763: CUSA Clarity Ultrasonic Surgical Aspirator System (Jul 15, 2022)
- K210128: INTEGRA Wound Matrix (Macro-Channels) (Oct 8, 2021)
- K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (Jul 27, 2021)

Source page: https://510kreport.com/company/integra-lifesciences