510(k) Report

FDA applicant

Regeneration Technologies, Inc.

Alachua, FL11 decisions2005–200826 recalls

FDA records 11 decisions for Regeneration Technologies, Inc. (Alachua, FL) from 2005 to 2008: 11 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and HWC (Screw, Fixation, Bone). Its devices cite 1 predicate, 1 of them its own earlier devices. 26 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 Regeneration Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 22008: 2
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2019

2011: 12013: 12017: 12019: 3
2007high 3 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Regeneration Technologies, 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 Compound5decisions
  • HWCScrew, Fixation, Bone4decisions
  • NUNBone Grafting Material, Human Source1decision
  • MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)1decision

Who builds on its devices?

Later devices cite its devices 14 times; 1 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.

  • K043420Osteofil, Optefil, Regenafil, Rti Allograft PasteRegeneration Technologies, Inc. · 20058cite it
  • K043421Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip ICRegeneration Technologies, Inc. · 20054cite it
  • K060253Sterling Interference Screw HT, Sterling Interference Screw ST.Regeneration Technologies, Inc. · 20061cites it
  • K052405Sterling Interferenc Screw HTRegeneration Technologies, Inc. · 20051cites it

What has FDA decided for it lately?

  • K080418Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset IC, Rti…Regeneration Technologies, Inc. · 2008
  • K072238Bioset XCHRegeneration Technologies, Inc. · 2008
  • K072327Cancello-Pure Bone Wedge, 12MM Evans or 6MM CottonRegeneration Technologies, Inc. · 2007
  • K063584Sterling IF Screw Eyelet, Model CID3936 and Sterling Cross-Pin Eyelet, Model CID3937Regeneration Technologies, Inc. · 2007
  • K060180Bioset XCRegeneration Technologies, Inc. · 2006
  • K060253Sterling Interference Screw HT, Sterling Interference Screw ST.Regeneration Technologies, Inc. · 2006
  • K052405Sterling Interferenc Screw HTRegeneration Technologies, Inc. · 2005
  • K051615Sterling Cancellous Chips; Sterling Cancellous CubesRegeneration Technologies, Inc. · 2005

All 11 as Regeneration Technologies, Inc. →

What has been recalled?

26 recalls linked to its devices; the latest:

  • K043421Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90Apr 26, 2019Class II
  • K043421Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45Apr 26, 2019Class II
  • K043421Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30Apr 26, 2019Class II
  • K043421RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in…Jan 23, 2017Class II
  • K043421***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in…Dec 6, 2013Class II
  • K043420***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed…Apr 9, 2011