510(k) Report

FDA applicant

Novosource, Inc.

Indianpolis, IN5 decisions2013–20261 recall

FDA records 5 decisions for Novosource, Inc. (Indianpolis, IN) from 2013 to 2026: 5 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and OQG (Hip Prosthesis, Semi-Constrained, Cemented…). Its devices cite 12 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “NovoSource”.

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 Novosource, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2013: 22014: 22026 (partial year): 1
2013high 2 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2013high 1 (2024) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Novosource, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novosource, 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?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3decisions
  • OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented1decision
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K132158Novohip Total Hip SystemNovosource, Inc. · 20143cite it
  • K123339TK1 Total Knee SystemNovosource, Inc. · 20132cite it
  • K131398Novoknee Total Knee SystemNovosource, Inc. · 20132cite it
  • K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 20141cites it

What has FDA decided for it lately?

  • K261032NovoKnee (SteriKnee)NovoSource · 2026
  • K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014
  • K132158Novohip Total Hip SystemNovosource, Inc. · 20141 recall
  • K131398Novoknee Total Knee SystemNovosource, Inc. · 2013
  • K123339TK1 Total Knee SystemNovosource, Inc. · 2013

All 4 as Novosource, Inc. →The one decision as NovoSource →

What has been recalled?

1 recall linked to its devices; the latest:

  • K132158NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total…Sep 19, 2024Class II