510(k) Report

FDA applicant

Avanta Orthopaedics, Inc.

San Diego, CA18 decisions1997–200340 recalls

FDA records 18 decisions for Avanta Orthopaedics, Inc. (San Diego, CA) from 1997 to 2003: 18 510(k) clearances. Most are in product codes KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer) and HRS (Plate, Fixation, Bone). Its devices cite 15 predicates, 4 of them its own earlier devices. 40 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 Avanta Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avanta Orthopaedics, Inc. since 2007.

Recalls per year

38in 2017

2013: 12017: 38
2007high 38 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Avanta Orthopaedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KWIProsthesis, Elbow, Hemi-, Radial, Polymer4decisions
  • HRSPlate, Fixation, Bone3decisions
  • KYIProsthesis, Wrist, Carpal Trapezium2decisions
  • KXEProsthesis, Wrist, Hemi-, Ulnar2decisions
  • JDWPin, Fixation, Threaded2decisions
  • KYJProsthesis, Finger, Constrained, Polymer1decision

Also: HXA (1), JDR (1), NDL (1), JWJ (1).

Whose devices does it build on?

Its devices cite 15 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 4 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.

  • K982288Radial Head ImplantAvanta Orthopaedics, Inc. · 19985cite it
  • K002644Radial Head ImplantAvanta Orthopaedics, Inc. · 20005cite it
  • K010786Ulnar Head ImplantAvanta Orthopaedics, Inc. · 20014cite it
  • K021859Wrist ImplantAvanta Orthopaedics, Inc. · 20023cite it
  • K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 20022cite it
  • K974911External FixatorAvanta Orthopaedics, Inc. · 19982cite it

What has FDA decided for it lately?

  • K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc. · 2003
  • K021859Wrist ImplantAvanta Orthopaedics, Inc. · 2002
  • K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 200218 recalls
  • K013629Finger Joint ProsthesisAvanta Orthopaedics, Inc. · 2002
  • K010847K'FIXAvanta Orthopaedics, Inc. · 2001
  • K011819Radial Head ImplantAvanta Orthopaedics, Inc. · 20011 recall
  • K003033Scaphix, Staple, Fixation, BoneAvanta Orthopaedics, Inc. · 2001
  • K010786Ulnar Head ImplantAvanta Orthopaedics, Inc. · 20011 recall

All 18 as Avanta Orthopaedics, Inc. →

What has been recalled?

40 recalls linked to its devices; the latest:

  • K023604rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of…Oct 24, 2017Class II
  • K023604rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the…Oct 24, 2017Class II
  • K002644rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of…Oct 24, 2017Class II
  • K002644rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the…Oct 24, 2017Class II
  • K002644radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the…Oct 24, 2017Class II
  • K023604rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the…Oct 24, 2017Class II