510(k) Report

FDA applicant

Link America, Inc.

East Hanavor, NJ21 decisions1984–199753 recalls

FDA records 21 decisions for Link America, Inc. (East Hanavor, NJ) from 1984 to 1997: 21 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and LZO (Prosthesis, Hip, Semi-Constrained…). 53 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 Link America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Link America, Inc. since 2007.

Recalls per year

32in 2023

2013: 212023: 32
2007high 32 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone3decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…3decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2decisions
  • JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)2decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2decisions
  • JDRStaple, Fixation, Bone2decisions

Also: HWC (2), KWS (1), KWP (1), JDJ (1), HSX (1), HTD (1).

Who builds on its devices?

Later devices cite its devices 16 times; 0 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.

  • K955296Link MP Reconstruction HipLink America, Inc. · 19967cite it
  • K954186Sled Unicompartment Knee SystemLink America, Inc. · 19966cite it
  • K854825Link Small Bone PlatesLink America, Inc. · 19861cites it
  • K854465Link Contour Ribbed Hip Prostheses SystemLink America, Inc. · 19861cites it
  • K914803Schwabe Radius PlatesLink America, Inc. · 19921cites it

What has FDA decided for it lately?

  • K972760Link, Acetabular Revision Mesh CupLink America, Inc. · 1997
  • K964458Ellis External Mini-Fixator SystemLink America, Inc. · 1996
  • K955296Link MP Reconstruction HipLink America, Inc. · 199621 recalls
  • K954186Sled Unicompartment Knee SystemLink America, Inc. · 199632 recalls
  • K931571Link Ceramic Heads 12/14 X 32MMLink America, Inc. · 1994
  • K931572Link Ceramic Heads 14/16 X 32MMLink America, Inc. · 1994
  • K920756Feldmuhle Ceramic HeadLink America, Inc. · 1992
  • K914804Radius Osteotomy PlatesLink America, Inc. · 1992

All 21 as Link America, Inc. →

What has been recalled?

53 recalls linked to its devices; the latest:

  • K954186LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07Mar 21, 2023Class II
  • K954186LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04Mar 21, 2023Class II
  • K954186LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07Mar 21, 2023Class II
  • K954186LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12Mar 21, 2023Class II
  • K954186LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02Mar 21, 2023Class II
  • K954186LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11Mar 21, 2023Class II