510(k) Report

FDA applicant

Implex Corp.

Allendale, NJ65 decisions1993–200520 recalls

FDA records 65 decisions for Implex Corp. (Allendale, NJ) from 1993 to 2005: 65 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and JDI (Prosthesis, Hip, Semi-Constrained…). Its devices cite 45 predicates, 32 of them its own earlier devices. 20 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Implex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Implex Corp. since 2007.

Recalls per year

2in 2019

2010: 22013: 12015: 12016: 62019: 2
2007high 6 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Implex Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Implex Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer17decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented10decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented10decisions
  • MQPSpinal Vertebral Body Replacement Device8decisions
  • EZXMesh, Surgical, Metal3decisions
  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…2decisions

Also: LWJ (2), MBH (2), LZO (2), FTM (1), KWT (1), JDK (1).

Whose devices does it build on?

Its devices cite 45 predicates; 32 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 81 times; 32 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010378Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZImplex Corp. · 20028cite it
  • K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 20036cite it
  • K022377The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306Implex Corp. · 20025cite it
  • K040487Trabecular Metal Knee System AugmentsImplex Corp. · 20044cite it
  • K984290Implex Radial Head Replacement SystemImplex Corp. · 19994cite it
  • K031462The Nexgen Knee System Uncemented ComponentsImplex Corp. · 20034cite it

What has FDA decided for it lately?

  • K051978Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
  • K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp. · 2005
  • K040487Trabecular Metal Knee System AugmentsImplex Corp. · 20041 recall
  • K040630Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZImplex Corp. · 20042 recalls
  • K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004
  • K031962Nexgen Trabecular Metal Tibial Cone AugmentsImplex Corp. · 2004
  • K033384The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZImplex Corp. · 2003
  • K032527Hedrocel Vertebral Body ReplacementImplex Corp. · 2003

All 65 as Implex Corp. →

What has been recalled?

20 recalls linked to its devices; the latest:

  • K024161NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM…Feb 1, 2019Class II
  • K024161NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM…Feb 1, 2019Class II
  • K031462TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB…Apr 15, 2016Class II
  • K031462TM Mono Tib STR GRN SZ 5 - 00588606510 TM Mono Tib STR GRN SZ 5 12MM - 00588606512 TM…Apr 15, 2016Class II
  • K031462Porous Patella 32MM X 10MM - 00587806532 Porous Patella 35MM X 10MM- 00587806535 Porous…Apr 15, 2016Class II
  • K980486Rev. Shell Liner 0D 28X48 00700504828 Rev. Shell Liner 10D 28X50 00701005028 Rev. Shell…Apr 15, 2016Class II