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FAQs

What is AUGMENT® Bone Graft?

FDA Approved medical device comprised of rhPDGF-BB and β-TCP that are mixed prior to implantation; β-TCP: 1.5cc and 3.0cc (particle size 1 to 2 mm) packaged along with corresponding size of rhPDGF-BB: 1.5mL and 3.0mL (0.3 mg/mL in 20mM USP sodium acetate buffer).

What is AUGMENT® Injectable?

FDA Approved medical device comprised of rhPDGF-BB and β-TCP with a collagen matrix that are mixed prior to implantation; β-TCP: 1.5cc and 3.0cc (particle size 100 to 300 µm) packaged along with corresponding size of rhPDGF-BB: 1.5mL and 3.0mL (0.3 mg/mL in 20mM USP sodium acetate buffer)

Does AUGMENT® currently have premarket approval or 510(k) approval from the FDA for its proposed use?

Yes. AUGMENT® is the first and only proven alternative to autograft for ankle and hindfoot arthrodesis and Approved by the FDA with a PMA (P100006).

What is the evidence supporting safety and effectiveness?

1. DiGiovanni CW, Lin SS, Daniels TR, Glazebrook M, Evangelista P, Donahue R, Beasley W, Baumhauer JF. The Importance of Sufficient Graft Material in Achieving Foot or Ankle Fusion. J Bone Joint Surg Am. 2016 Aug 3;98(15):1260-7.  doi: 10.2106/JBJS.15.00879. PMID: 27489316. READ MORE
2. DiGiovanni CW, Lin SS, Baumhauer JF, Daniels T, Younger A, Glazebrook M, Anderson J, Anderson R, Evangelista P, Lynch SE, et al. Recombinant Human Platelet-Derived Growth Factor-BB and Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP): An Alternative to Autogenous Bone Graft. J Bone Joint Surg Am. 2013 Jul 3;95(13):1184-92. doi: 10.2106/JBJS.K.01422. PubMed PMID: 23824386*. READ MORE
*FDA did not base its approval of AUGMENT® Bone Graft on radiologic findings from the pivotal study, but instead relied on clinical outcomes.
3. Friedlaender GE, Lin S, Solchaga LA, Snel LB, Lynch SE. The role of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) in orthopaedic bone repair and regeneration. Curr Pharm Des. 2013 Feb 11. [Epub ahead of print]. PubMed PMID: 23432673. READ MORE
4. Solchaga LA, Daniels T, Roach S, Beasley W, Snel LB. Effect of implantation of AUGMENT® Bone Graft on serum concentrations of platelet-derived growth factors: a pharmacokinetic study. Clin Drug Investig. 2013 Feb;33(2):143-9. doi: 10.1007/s40261- 013-0053-5. PubMed PMID: 23334906. READ MORE
5. Glazebrook M, Daniels T, Abidi N, Younger A, DiGiovanni CW. Role of Platelet-derived Growth Factor in Hindfoot Fusion. Techniques in Foot & Ankle Surgery. 11(1):34-38, March 2012. doi: 10.1097/ BTF.0b013e3182469626. READ MORE
6. DiGiovanni CW, Lin S, Pinzur M. Recombinant human PDGF-BB in foot and ankle fusion. Expert Rev Med Devices. 2012 Mar;9(2):111-22. doi: 10.1586/erd.11.76. Review. PubMed PMID: 22404772. READ MORE
7. DiGiovanni CW, Baumhauer J, Lin SS, Berberian WS, Flemister AS, Enna MJ, Evangelista P, Newman J. Prospective, randomized, multi-center feasibility trial of rhPDGF-BB versus autologous bone graft in a foot and ankle fusion model. Foot Ankle Int. 2011 Apr;32(4):344-54. doi: 10.3113/FAI.2011.0344. PubMed PMID: 21733435. READ MORE
8. DiGiovanni CW, Petricek JM. The evolution of rhPDGF-BB in musculoskeletal repair and its role in foot and ankle fusion surgery. Foot Ankle Clin. 2010 Dec;15(4):621-40. doi: 10.1016/j.fcl.2010.07.001. Review. PubMed PMID: 21056861. READ MORE
9. Daniels T, DiGiovanni C, Lau JT, Wing K, Younger A. Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses. Foot Ankle Int. 2010 Jun;31(6):473-9. doi: 10. 3113/FAI.2010.0473. PubMed PMID: 20557811. READ MORE
10. Hollinger JO, Hart CE, Hirsch SN, Lynch S, Friedlaender GE. Recombinant human platelet-derived growth factor: biology and clinical applications. J Bone Joint Surg Am. 2008 Feb;90 Suppl 1:48-54. doi: 10.2106/ JBJS.G.01231. Review. PubMed PMID: 18292357. READ MORE
11. Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. PubMed PMID: 16332231. READ MORE

Does the product contain latex?

No

Does this item require special storage considerations?

Refrigerated (2-8°C). Download PDF

Are there multiple sizes available?

Part No.DescriptionVolume
K30030010AUGMENT® Injectable3.0cc
K30015010AUGMENT® Injectable1.5cc
K20003010AUGMENT® Bone Graft3.0cc
K20001510AUGMENT® Bone Graft1.5cc
CK20004510AUGMENT® Bone Graft4.5cc

How much AUGMENT® used in a particular case is always a clinical decision, but here are some guidelines on how much is used on average for the procedures listed below, based on our past experience selling AUGMENT®?

ProcedureNumber of kits usedVolume of kit
Ankle fusion1-23cc
Isolated TN or CC11.5cc
Double arthrodesis13cc
Triple arthrodesis2-33cc
TTC2-33cc
Pantalor2-33cc

Is AUGMENT® a tissue?

No. AUGMENT® is a Class III combination drug/device product that includes a synthetically engineered human growth factor, but includes no human tissue, and should not be treated as a tissue. Download PDF

What are the part numbers?

Part No.DescriptionVolume
K30030010AUGMENT® Injectable3.0cc
K30015010AUGMENT® Injectable1.5cc
K20003010AUGMENT® Bone Graft3.0cc
K20001510AUGMENT® Bone Graft1.5cc
CK20004510AUGMENT® Bone Graft4.5cc

What is shelf life from date of manufacture?

3 years