510(k) Report

FDA applicant

Therics, Inc.

Princeton, NJ4 decisions2003–20063 recalls

FDA records 4 decisions for Therics, Inc. (Princeton, NJ) from 2003 to 2006: 4 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Therics, LLC”.

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

FDA decisions per year

No FDA decision for Therics, Inc. since 2007.

Recalls per year

1in 2010

2008: 22010: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Therics, Inc.’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?

  • MQVFiller, Bone Void, Calcium Compound3decisions
  • LYCBone Grafting Material, Synthetic1decision

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.

  • K023998Theriridge Block, Bone Graft SubstituteTherics, Inc. · 20031cites it
  • K031040Therifil Bone FillerTherics, Inc. · 20031cites it

What has FDA decided for it lately?

  • K053228Therigraft TCP Putty Bone Void FillerTherics, LLC · 20062 recalls
  • K040134Therilink Bone Void FillerTherics, Inc. · 20041 recall
  • K031040Therifil Bone FillerTherics, Inc. · 2003
  • K023998Theriridge Block, Bone Graft SubstituteTherics, Inc. · 2003

All 3 as Therics, Inc. →The one decision as Therics, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K053228Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered…Aug 26, 2010
  • K040134iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model…Aug 26, 2008
  • K053228FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in…Jul 11, 2008