510(k) Report

FDA applicant

Synthes (Usa) Products, LLC/Norian Corporation

West Chester, PA1 decision2011–20112 recalls

FDA records 1 decision for Synthes (Usa) Products, LLC/Norian Corporation (West Chester, PA) in 2011: 1 510(k) clearance. All are in product code MTJ (Wax, Bone). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Synthes (Usa) Products, LLC/Norian Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2012

2012: 2, 1 Class I
2011high 2 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Synthes (Usa) Products, LLC/Norian Corporation by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MTJWax, Bone1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 20112cite it

What has FDA decided for it lately?

  • K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 20111 Class I recall

The one decision as Synthes (Usa) Products, LLC/Norian Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K103822Synthes (R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S…Jul 5, 2012Class I
  • K113079Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the…Jan 6, 2012Class II

Other applicant names beginning “Synthes”

FDA records each applicant name separately; these may or may not be the same firm.

Synthes (Usa) 419Synthes (USA) Products, LLC 61Synthes Spine 54Synthes 26Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. 5