510(k) Report

FDA applicant

Dvo Extremity Solutions, LLC

Derby, CT4 decisions2005–200813 recalls

FDA records 4 decisions for Dvo Extremity Solutions, LLC (Derby, CT) from 2005 to 2008: 4 510(k) clearances. Most are in product codes KWS (Prosthesis, Shoulder, Semi-Constrained…) and HRS (Plate, Fixation, Bone). Its devices cite 8 predicates, 1 of them its own earlier devices. 13 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 Dvo Extremity Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

13in 2008

2008: 13
2007high 13 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Dvo Extremity Solutions, LLC’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?

  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1decision
  • HRSPlate, Fixation, Bone1decision
  • HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1decision
  • LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 1 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.

  • K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 20066cite it
  • K052754Wrist Fusion PlateDvo Extremity Solutions, LLC · 20052cite it
  • K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC · 20081cites it

What has FDA decided for it lately?

  • K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC · 2008
  • K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 200613 recalls
  • K052754Wrist Fusion PlateDvo Extremity Solutions, LLC · 2005
  • K052150Volar Plate SystemDvo Extremity Solutions, LLC · 2005

All 4 as Dvo Extremity Solutions, LLC →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K060988Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile. Manufactured…Oct 20, 2008
  • K060988Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Manufactured…Oct 20, 2008
  • K060988Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile.…Oct 20, 2008
  • K060988Tornier AFFINITI Humeral Head Eccentric 52mm x 21mm, Catalog No. 0020034. Sterile.…Oct 20, 2008
  • K060988Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. Sterile.…Oct 20, 2008
  • K060988Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile.…Oct 20, 2008