510(k) Report

FDA applicant

Bacterin International, Inc.

Belgrade, MT4 decisions2007–20155 recalls

FDA records 4 decisions for Bacterin International, Inc. (Belgrade, MT) from 2007 to 2015: 4 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and MBP (Filler, Bone Void, Osteoinduction (W/O Human…). Its devices cite 11 predicates, 3 of them its own earlier devices. 5 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 Bacterin International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12009: 12013: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2019

2012: 12013: 22014: 12019: 1
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Bacterin International, 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 Compound2decisions
  • MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)1decision
  • OEIDrainage Catheter With Antibiotic1decision

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091321Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 20092cite it
  • K130498Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 20131cites it

What has FDA decided for it lately?

  • K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc. · 2015
  • K130498Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 20131 recall
  • K091321Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 20092 recalls
  • K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 20072 recalls

All 4 as Bacterin International, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K130498OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R…May 3, 2019Class II
  • K063245Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound…May 15, 2014Class II
  • K091321OsteoSelect DBM Putty Product Usage: Orthopedic bone fillerFeb 21, 2013Class II
  • K063245Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless…Jan 28, 2013Class II
  • K091321Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID#…Apr 18, 2012Class II