# Implex Corp.

- Location (FDA's records): Allendale, NJ
- FDA decisions: 65 (1993–2005): 65 510(k) clearances
- Product codes: JWH (17), JDI (10), LPH (10), MQP (8), EZX (3), MEH (2), LWJ (2), MBH (2), LZO (2), FTM (1), KWT (1), JDK (1)
- Predicates its devices cite: 45 (32 its own); citations of its devices by later devices: 81 (32 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Corp.: 4 (https://510kreport.com/company/howmedica)
- Buckman Co., Inc.: 3 (https://510kreport.com/company/buckman)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Osteonics Corp.: 1 (https://510kreport.com/company/osteonics)
- Smith & Nephew Richards, Inc.: 1 (https://510kreport.com/company/smith-nephew-richards)
- Richards Medical Co., Inc.: 1 (https://510kreport.com/company/richards-medical)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)

## Firms that cite its devices most
- Zimmer Trabecular Metal Technology: 13 (https://510kreport.com/company/zimmer-trabecular-metal-technology)
- Zimmer Trabecular: 11 (https://510kreport.com/company/zimmer-trabecular)
- Zimmer, Inc.: 8 (https://510kreport.com/company/zimmer)
- Biomet Manufacturing Corp: 7 (https://510kreport.com/company/biomet-manufacturing)
- Biomet, Inc.: 5 (https://510kreport.com/company/biomet)
- Plus Orthopedics: 1 (https://510kreport.com/company/plus-orthopedics)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K010378: Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ (2002), cited by 8
- K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments (2003), cited by 6
- K022377: The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306 (2002), cited by 5
- K040487: Trabecular Metal Knee System Augments (2004), cited by 4
- K984290: Implex Radial Head Replacement System (1999), cited by 4
- K031462: The Nexgen Knee System Uncemented Components (2003), cited by 4

## Recent decisions
- K051978: Trabecular Metal Vertebral Body Replacement (Sep 23, 2005)
- K051196: Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1 (Jun 17, 2005)
- K040487: Trabecular Metal Knee System Augments (Dec 21, 2004)
- K040630: Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ (Sep 30, 2004)
- K040756: The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx (Jul 14, 2004)
- K031962: Nexgen Trabecular Metal Tibial Cone Augments (Jan 8, 2004)
- K033384: The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ (Nov 19, 2003)
- K032527: Hedrocel Vertebral Body Replacement (Oct 31, 2003)

Source page: https://510kreport.com/company/implex