510(k) Report

FDA applicant

Orthovita, Inc.

Malver, PA26 decisions1995–20178 recalls

FDA records 26 decisions for Orthovita, Inc. (Malver, PA) from 1995 to 2017: 26 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 214 for FDA’s reviews in the same codes and years. Its devices cite 48 predicates, 23 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Orthovita Co.”.

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

FDA decisions per year

1in 2017

2007: 12008: 22009: 12010: 22011: 22014: 22015: 12016: 22017: 1
2007high 2 (2008) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2021

2011: 12012: 12014: 12018: 22020: 12021: 2
2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Orthovita, 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?

  • MQVFiller, Bone Void, Calcium Compound12decisions
  • FMFSyringe, Piston4decisions
  • LYCBone Grafting Material, Synthetic3decisions
  • KNWInstrument, Biopsy2decisions
  • NDNCement, Bone, Vertebroplasty1decision
  • HAWNeurological Stereotaxic Instrument1decision

Also: MQP (1), ODP (1), LXH (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 214 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 48 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 117 times; 23 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.

  • K994337Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 200026cite it
  • K032288Vitoss Scaffold Foam Bone Graft MaterialOrthovita, Inc. · 200317cite it
  • K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft…Orthovita, Inc. · 200811cite it
  • K032409Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc. · 20038cite it
  • K030208Imbibe II SyringeOrthovita, Inc. · 20037cite it
  • K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 20086cite it

What has FDA decided for it lately?

  • K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
  • K161447HydroSet XTOrthovita, Inc. · 20162 recalls
  • K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
  • K153306Imbibe NeedleOrthovita, Inc. · 2015
  • K140868Stryker Kwic NeedleOrthovita, Inc. · 2014
  • K140414Imbibe NeedleOrthovita, Inc. · 20141 recall
  • K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
  • K101171Orthovita Peek SpacerOrthovita, Inc. · 2011

All 23 as Orthovita, Inc. →All 3 as Orthovita Co. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K080108Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN…May 18, 2021Class II
  • K080108Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN…May 18, 2021Class II
  • K080108Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010Apr 1, 2020Class II
  • K161447HydroSet XT Injectable HA Bone Cement, REF 897005, STERILENov 15, 2018Class II
  • K161447HydroSet XT Injectable HA Bone Cement, REF 897003, STERILENov 15, 2018Class II
  • K140414Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027…Dec 4, 2014Class II