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Table 1 Topics of the Orthopaedic and Rehabilitation Devices Panel 2000–2016

From: Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs

Number

Date

Sponsor

Device

1

April 20, 2016

Cartiva

Synthetic Cartilage Implant [20]

2

February 19, 2015

Medtronic

DIAM Spinal Stabilization System [38]

3

February 20, 2015

Vertiflex

Superion Spinous Process Spacer [16]

4

February 21, 2014

N/A

Iontophoresis [39]

5

December 12, 2013

N/A

Spinal Spheres [40]

6

December 12, 2013

N/A

Stair climbing wheelchairs [41]

7

December 12, 2013

N/A

Mechanical wheelchairs [42]

8

May 22, 2013

N/A

Pedicle screw spinal systems [43]

9

May 21, 2013

N/A

Nonthermal short wave diathermy [44]

10

September 21, 2012

N/A

Posterior cervical pedicle/lateral mass screw spinal systems [45]

11

June 27–28, 2012

N/A

Metal-on-metal hip implant systems [31]

12

May 12, 2011

BioMimetic

Augment Bone Graft [6]

13

May 27, 2010

Medtronic

Amplify rhBMP-2 Matrix [7]

14

March 23, 2010

ReGen Biologics

Collagen Scaffold (CS)/Menaflex

15

November 4, 2009

Zimmer Spine

Dynesys Spinal System [8]

16

August 19, 2009

Q-Med

Durolane [46]

17

August 18, 2009

DePuy Orthopaedics

CoMplete Acetabular Hip System [47]

18

March 31, 2009

Stryker Biotech

OP-1 Putty [48]

19

December 9, 2008

Genzyme

Synvisc One [49]

20

November 14, 2008

ReGen Biologics

Collagen Scaffold (CS)/Menaflex

21

July 15, 2008

FzioMed

Oxiplex/SP Gel [50]

22

July 17, 2007

Medtronic

Bryan Cervical Disc [51]

23

April 24, 2007

Link America

Scandinavian Total Ankle Replacement (STAR) System [52]

24

February 22, 2007

Corin USA

Cormet 2000 Hip Resurfacing System [53]

25

September 19, 2006

Medtronic

Prestige Cervical Disc System [29]

26

June 2, 2006

RS Medical

Non-invasive Bone Growth Stimulator [54]

27

September 8, 2005

Smith & Nephew

Birmingham Hip Resurfacing System

28

September 9, 2005

N/A

Design of clinical studies for spinal devices

29

August 31, 2004

St. Francis Medical

X STOP Interspinous Process Decompression System [30]

30

June 3, 2004

OSMA

Knee mobile bearing and unicompartmental arthroplasty [55]

31

June 3, 2004

OSMA

Total knee and total hip [55]

32

June 2, 2004

DePuy Spine

Charité Artificial Disc [28]

33

December 11, 2003

N/A

Intervertebral body fusion device [56]

34

November 21, 2002

Wyeth

InductOs rhBMP-2/absorbable collagen sponge [57]

35

November 20, 2002

Independence

iBOT 3000 Mobility System [58]

36

January 10, 2002

Medtronic

InFUSE rhBMP-2/absorbable collagene sponge [59]

37

July 20, 2000

HealthTronic

OssaTron Lithotripter [4]

38

July 20, 2000

Howmedica

ABC and Trident Acetabular Systems [4]