510(k) Report

FDA applicant

Dow Corning Wright

Arlington, TN74 decisions1979–19942 recalls

FDA records 74 decisions for Dow Corning Wright (Arlington, TN) from 1979 to 1994: 74 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LZO (Prosthesis, Hip, Semi-Constrained…). 2 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 Dow Corning Wright’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dow Corning Wright since 2007.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dow Corning Wright 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?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer24decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…7decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5decisions
  • HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer4decisions
  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…3decisions
  • JDGProsthesis, Hip, Femoral Component, Cemented, Metal3decisions

Also: HRY (2), HWC (2), JDL (2), KYI (2), MCW (2), GZT (1).

Who builds on its devices?

Later devices cite its devices 34 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.

  • K864491Swanson Titanium Carpal Lunate ImplantDow Corning Wright · 19873cite it
  • K894226Silastic Soft SheetingDow Corning Wright · 19903cite it
  • K864488Swanson Titanium Condylar ImplantDow Corning Wright · 19873cite it
  • K792670Smith Subtalar PegDow Corning Wright · 19803cite it
  • K864490Swanson Titanium Carpal Scaphoid ImplantDow Corning Wright · 19872cite it
  • K932222SLT Femoral HeadDow Corning Wright · 19942cite it

What has FDA decided for it lately?

  • K932210Ortholoc Advantim Revision Femoral ComponentDow Corning Wright · 1994
  • K932911Ortholoc Advantim L.S. Tibial ComponentDow Corning Wright · 1994
  • K934354Lacey All Polyethylene Tibial ComponentDow Corning Wright · 1994
  • K932222SLT Femoral HeadDow Corning Wright · 1994
  • K932858Ortholoc Advantim Tibial Base ComponentDow Corning Wright · 1994
  • K930228Ortholoc Advantim Tibial Stem 5 DegreeDow Corning Wright · 1993
  • K925900Lacey Revision Femoral ComponentDow Corning Wright · 1993
  • K930189Ortholoc (R) Advantim (TM) Posterior Stab Femor CompDow Corning Wright · 1993

All 74 as Dow Corning Wright →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K864489SWANSON TRAPEZIUM IMPLANT, Part Number 4520002Nov 8, 2016Class II
  • K864492SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104Nov 8, 2016Class II