510(k) Report

FDA applicant

Consensus Orthopedics, Inc.

El Dorado Hills, CA17 decisions2010–20170 recalls

FDA records 17 decisions for Consensus Orthopedics, Inc. (El Dorado Hills, CA) from 2010 to 2017: 17 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 268 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 122 predicates, 19 of them its own earlier devices. No recall is 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 Consensus Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2010: 32011: 32012: 42013: 12014: 22015: 12016: 12017: 2
2010high 4 (2012) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Consensus Orthopedics, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented7decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5decisions
  • MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated…2decisions
  • HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer1decision
  • OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented1decision
  • LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 268 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 122 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 19 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.

  • K110950Consensus Knee SystemConsensus Orthopedics, Inc. · 20118cite it
  • K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 20107cite it
  • K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 20105cite it
  • K100542Consensus Revision Knee SystemConsensus Orthopedics, Inc. · 20105cite it
  • K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 20142cite it
  • K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 20142cite it

What has FDA decided for it lately?

  • K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  • K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
  • K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
  • K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
  • K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
  • K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 2014
  • K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc. · 2013
  • K122512CS2 Hip SystemConsensus Orthopedics, Inc. · 2012

All 17 as Consensus Orthopedics, Inc. →