510(k) Report

FDA applicant

Sulzermedica

Austin, TX6 decisions1997–20002 recalls

FDA records 6 decisions for Sulzermedica (Austin, TX) from 1997 to 2000: 5 510(k) clearances and 1 original PMA approval. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and MBD (Prosthesis, Knee, Patello/Femorotibial…). 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 Sulzermedica’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sulzermedica since 2007.

Recalls per year

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sulzermedica 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?

  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter3decisions
  • MBDProsthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated…1decision
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision
  • KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)1decision

Who builds on its devices?

Later devices cite its devices 6 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.

  • P940002Natural-Knee (R) and Natural Knee (R)II W/Csti (TM)Sulzermedica · 19972cite it
  • K992832Sulzer Vascutek Eptfe Vascular ProsthesisSulzermedica · 19992cite it
  • K002324Modified to Modular FR Severe Bone Loss TraumaSulzermedica · 20001cites it
  • K990503Sulzer Vascutek Gelsoft Vascular ProsthesisSulzermedica · 19991cites it

What has FDA decided for it lately?

  • K002324Modified to Modular FR Severe Bone Loss TraumaSulzermedica · 20001 recall
  • K993667Sulzer Vascutek Sealptfe Vascular ProsthesisSulzermedica · 2000
  • K990503Sulzer Vascutek Gelsoft Vascular ProsthesisSulzermedica · 19991 recall
  • K993569Apr Metasul Acetabular InsertSulzermedica · 1999
  • K992832Sulzer Vascutek Eptfe Vascular ProsthesisSulzermedica · 1999
  • P940002Natural-Knee (R) and Natural Knee (R)II W/Csti (TM)Sulzermedica · 1997

All 6 as Sulzermedica →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K990503Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin…Oct 23, 2013Class II
  • K0023245100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to…Nov 15, 2011