Table 2.
Premarket approvals with investigational device exemption trials 2000–2016
| Number | Date | Sponsor | Device | ||
|---|---|---|---|---|---|
| 1 | April 20, 2016 | Cartiva | Synthetic Cartilage Implant | ||
| 2 | February 19, 2015 | Medtronic | DIAM Spinal Stabilization System | ||
| 3 | February 20, 2015 | Vertiflex | Superion Spinous Process Spacer [16] | ||
| 4 | May 12, 2011 | BioMimetic | Augment Bone Graft [6] | ||
| 5 | May 27, 2010 | Medtronic | Amplify rhBMP-2 Matrix [7] | ||
| 6 | November 4, 2009 | Zimmer Spine | Dynesys Spinal System [8] | ||
| 7 | August 19, 2009 | Q-Med | Durolane [46] | ||
| 8 | August 18, 2009 | DePuy Orthopaedics | CoMplete Acetabular Hip System [47] | ||
| 9 | March 31, 2009 | Stryker Biotech | OP-1 Putty [48] | ||
| 10 | December 9, 2008 | Genzyme | Synvisc One [49] | ||
| 11 | November 14, 2008 | ReGen Biologics | Collagen Scaffold (CS)/Menaflex | ||
| 12 | July 15, 2008 | FzioMed | Oxiplex/SP Gel [50] | ||
| 13 | July 17, 2007 | Medtronic | Bryan Cervical Disc [51] | ||
| 14 | April 24, 2007 | Link America | Scandinavian Total Ankle Replacement (STAR) System [52] | ||
| 15 | February 22, 2007 | Corin USA | Cormet 2000 Hip Resurfacing System [53] | ||
| 16 | September 19, 2006 | Medtronic | Prestige Cervical Disc System [29] | ||
| 17 | September 8, 2005 | Smith & Nephew | Birmingham Hip Resurfacing System | ||
| 18 | August 31, 2004 | St. Francis Medical | X STOP Interspinous Process Decompression System [30] | ||
| 19 | June 2, 2004 | DePuy Spine | Charité Artificial Disc [28] | ||
| 20 | November 21, 2002 | Wyeth | InductOs rhBMP-2/absorbable collagen sponge [57] | ||
| 21 | November 20, 2002 | Independence | iBOT 3000 Mobility System [58] | ||
| 22 | January 10, 2002 | Medtronic | InFUSE rhBMP-2/absorbable collagene sponge [59] | ||
| 23 | July 20, 2000 | HealthTronic | OssaTron Lithotripter [4] | ||
| Number | Filing | Design | Type | Arms | Control |
| 1 | PMA (P150017) | RCT | Non-inferiority | 2 | Active |
| 2 | PMA (1400007) | RCT | Superiority | 2 | Usual care |
| 3 | PMA (P140004) | RCT | Non-inferiority | 2 | Active |
| 4 | PMA (P100006) | RCT | Non-inferiority | 2 | Active |
| 5 | PMA (P050036) | RCT | Non-inferiority | 2 | Active |
| 6 | PMA (P070031) | RCT | Non-inferiority | 2 | Active |
| 7 | PMA (P060013) | RCT | Superiority | 2 | Sham |
| 8 | PMA (P090002) | RCT | Non-inferiority | 2 | Active |
| 9 | PMA (P060021) | RCT | Non-inferiority | 2 | Active |
| 10 | PMA (P940015) | RCT | Superiority | 2 | Sham |
| 11 | 510(k) (K082079) | RCT | Superiority | 2 | Active |
| 12 | PMA (P070023) | RCT | Superiority | 2 | Active |
| 13 | PMA (P060023) | RCT | Non-inferiority | 2 | Active |
| 14 | PMA (P050050) | RCT | Non-inferiority | 2 | Active |
| 15 | PMA (P050016) | Non-randomized | Non-inferiority | 2 | Active |
| 16 | PMA (P060018) | RCT | Non-inferiority | 2 | Active |
| 17 | PMA (P040033) | Observational | – | – | – |
| 18 | PMA (P040001) | RCT | Superiority | 2 | Usual care |
| 19 | PMA (P040006) | RCT | Non-inferiority | 2 | Active |
| 20 | PMA (P000054) | RCT | Superiority | 2 | Active |
| 21 | PMA (P020033) | Observational | Crossover | 2 | Usual care |
| 22 | PMA (P000058) | RCT | Non-inferiority | 2 | Active |
| 23 | PMA (P990086) | RCT | Superiority | 2 | Sham |
IDE investigational device exemption, PMA premarket approval, RCT randomized controlled trial