510(k) Approvals
BY EDITOR, JUNE 21, 2004
Device
Applicant
510(k)
Decision Date
1
acumed lower extremity congruent plate s
acumed llc
K033639
1/15/2004
2
titanium cannulated interference screw
advanced biomaterial
K033749
2/23/2004
3
aesculap absorbable craniofix
aesculap, inc.
K040080
3/31/2004
4
abc caudal and cranial extension plate
aesculap, inc.
K040017
5/14/2004
5
apapore bone graft substitute
apatech ltd.
K033722
5/7/2004
6
arthrex fibertape (tm), 2mm, arthrex fib
arthrex, inc.
K032245
1/14/2004
7
hatric, 6&7mm, 9&10m
arthrex, inc.
K040381
5/12/2004
8
arthrocare controller, cable, foot contr
arthrocare corp.
K040338
3/1/2004
9
cap great toe resurfacing hemi-arthropla
arthrosurface, inc.
K031859
2/18/2004
10
maxbraid polyester plus and polyethylene
arthrotek, inc.
K033718
2/12/2004
11
arthrotek lactonail
arthrotek, inc.
K040500
5/25/2004
12
cem-ostetic putty injection kit, model p
berkeley advanced bi
K040405
3/5/2004
13
bilok st screw
biocomposites ltd.
K033792
3/1/2004
14
genex bone graft substitute
biocomposites ltd.
K040600
5/7/2004
15
little grafter screw
biocomposites ltd.
K040265
5/28/2004
16
bmr neurotech back tens and lumbar support
bio-medical research
K023916
4/15/2004
17
titanium toggle buttons(s)
biomet manufacturing
K033838
2/13/2004
18
vanguard patella components
biomet manufacturing
K040770
4/22/2004
19
versa-dial humeral head
biomet manufacturing
K040610
6/4/2004
20
comprehensive humeral fracture positioni
biomet, inc.
K033506
2/2/2004
21
im total femur
biomet, inc.
K033871
4/16/2004
22
calcigen -nap bone void filler
biomet, inc.
K033611
4/27/2004
23
micromax suture anchor
biomet, inc.
K040475
5/21/2004
24
maxim accel (vanguard) PS+ bearings
biomet, inc.
K041046
5/21/2004
25
agc total knee system knee, ascent total
biomet, inc.
K033489
6/2/2004
26
modular radial head replacement device
biomet, inc.
K040611
6/4/2004
27
pelvis bellyboard plus patient positioni
bionix development c
K040773
4/9/2004
28
modification to triage b-type natriureti
biosite incorporated
K032235
1/28/2004
29
blackstone ascent poct system lateral of
blackstone medical,
K040034
2/11/2004
30
blackstone ascent poct system hooks (sys
blackstone medical,
K033980
3/3/2004
31
blackstone peek vertebral body replacement
blackstone medical,
K033702
3/31/2004
32
transet fracture fixation system
bonutti research, in
K033717
2/25/2004
33
vectorvision cranial/ent
brainlab ag
K023651
2/17/2004
34
table tilt device
brainlab ag
K033316
5/14/2004
35
bone cement for cranioplasty
cardinal health
K040152
5/19/2004
36
natural-knee ii unicompartmental knee sy
centerpulse orthoped
K033810
3/5/2004
37
dynesys spinal system
centerpulse spine-te
K031511
3/5/2004
38
vectra transportable combo and stim (spe
chattanooga group
K040285
4/12/2004
39
codman dural graft implant, models 80-14
codman & shurtleff,
K033395
2/25/2004
40
modification to: collagen topical wound
collagen matrix, inc
K040211
2/27/2004
41
hero 1, model ly-esb220
comfort orthopedic c
K031621
1/22/2004
42
ace proximal humeral nail system
depuy ace
K033806
2/20/2004
43
ace antegrade retrograde humeral nail sy
depuy ace
K033878
2/20/2004
44
eagle anterior cervial plate system
depuy acromed
K040197
4/2/2004
45
orthocord suture
depuy mitek
K040004
4/13/2004
46
panalok rc loop anchor
depuy mitek
K041065
5/7/2004
47
bioknotless rc anchor
depuy mitek
K041064
5/13/2004
48
super quickanchor plus
depuy mitek
K041116
5/28/2004
49
panalok rc quickanchor plus, model 21213
depuy mitek
K041117
5/28/2004
50
panalok loop anchor
depuy mitek, a johns
K040827
4/30/2004
51
vapr 3 electrosurgical system and vapr l
depuy mitek, a johns
K041135
5/10/2004
52
gii quickanchor plus
depuy mitek, a johns
K041115
5/28/2004
53
depuy sigma tibial inserts
depuy orthopaedics,
K033272
2/5/2004
54
smartset gmv endurance gentamicin bone c
depuy orthopaedics,
K033382
2/5/2004
55
smartset ghv gentamicin bone cement
depuy orthopaedics,
K033563
2/5/2004
56
depuy sigma xlk tibial inserts
depuy orthopaedics,
K040166
2/23/2004
57
spectrum modular system
depuy orthopaedics,
K033893
3/12/2004
58
modification to depuy ceramic femoral he
depuy orthopaedics,
K040644
4/8/2004
59
depuy preservation unicondylar tibia
depuy orthopaedics,
K040268
5/5/2004
60
depuy pinnacle acetabular cup system, es
depuy orthopaedics,
K033273
5/6/2004
61
triflange ii acetabular cup system
depuy orthopaedics,
K040383
5/12/2004
62
pinnacle revision system
depuy orthopaedics,
K033338
1/8/2004
63
summit oct spinal system
depuy spine, inc.
K041203
6/2/2004
64
merlin spine system
depuy spine,inc
K033901
3/31/2004
65
swift anterior cervical plate system
depuy spine,inc
K040655
6/2/2004
66
duraloc option acetabular cup system, mo
depuy, inc.
K040544
5/28/2004
67
fixion hip system
disc-o-tech medical
K032730
3/26/2004
68
sky bone expander system (sky system)
disc-o-tech medical
K040939
5/12/2004
69
sky bone expander system
disc-o-tech medical
K034037
1/28/2004
70
ebi top loading mas spinal fixation syst
ebi, l.p.
K033312
1/13/2004
71
ebi esl spine spacer system
ebi, l.p.
K040482
4/16/2004
72
titanium mesh system
encore medical, l.p.
K032371
2/12/2004
73
modification to cyclone anterior cervica
encore medical, l.p.
K040397
5/6/2004
74
mammotome ex hand held system
ethicon endo-surgery
K033700
2/20/2004
75
orthopacs
etrauma.com corp.
K033825
2/2/2004
76
eovia calcium phosphate ceramic
eurosurgical s.a.
K040514
5/3/2004
77
spacer g temporary hip prosthesis
exactech, inc.
K031841
1/22/2004
78
optetrak total knee system, hi-flex asym
exactech, inc.
K033883
2/13/2004
79
exactech resorbable bone paste
exactech, inc.
K020078
2/27/2004
80
cemex genta bone cement; cemex genta sys
exactech, inc.
K033596
5/10/2004
81
tecres spacer-k temporary knee prosthesi
exactech, inc.
K032522
5/28/2004
82
exactech acumatch a-series and mcs aceta
exactech, inc.
K040613
6/4/2004
83
lightspeed 7.0 ct scanner system
ge medical systems,
K040372
3/1/2004
84
genzyme osom trichomonas rapid test
genzyme corp.
K033864
4/2/2004
85
small bone fixation system
hand innovations, in
K033406
1/15/2004
86
eius unicompartmental knee system
howmedica osteonics
K033769
2/13/2004
87
stryker spine oasys system
howmedica osteonics
K032394
2/20/2004
88
hansson pin system
howmedica osteonics
K033968
2/20/2004
89
bonesave bone void filler
howmedica osteonics
K033258
3/9/2004
90
modification to modular replacement syst
howmedica osteonics
K040128
3/26/2004
91
scorpio total knee system
howmedica osteonics
K033972
4/12/2004
92
triathlon cruciate retaining (cr) total
howmedica osteonics
K040267
5/5/2004
93
avon extra-small patello-femoral replace
howmedica osteonics
K041160
5/27/2004
94
scorpio total knee system with peri-apat
howmedica osteonics
K033971
5/28/2004
95
scorpio total knee system - posterior st
howmedica osteonics
K040964
5/28/2004
96
stryker spine vertebral body support sys
howmedica osteonics
K033837
1/8/2004
97
scorpio knee system - tibial inserts
howmedica osteonics
K033342
1/15/2004
98
gamma3 nail system
howmedica osteonics
K034002
1/15/2004
99
modification to hoffman ii micro extern
howmedica osteonics
K033476
1/20/2004
100
i-flow elastomeric pump (on-q, painbuste
i-flow corp.
K040337
5/24/2004
101
nexgen trabecular metal tibial cone augm
implex corp.
K031962
1/8/2004
102
inion gtr biodegradable membrane system
inion ltd.
K033074
3/31/2004
103
licox pmo brain monitoring system
integra lifesciences
K040235
4/20/2004
104
modification to burr hole valve and shun
integra neuroscience
K040201
2/26/2004
105
modification to geo structure
interpore cross intl
K040168
4/8/2004
106
altius oct system
interpore cross intl
K033961
4/14/2004
107
kompressor screw system
kinetikos medical, i
K040356
3/1/2004
108
katalyst radial head implant
kinetikos medical, i
K032806
4/16/2004
109
kyphx hv-r, model c01a
kyphon, inc.
K033801
4/1/2004
110
cannulated nugen fx screw fully threaded
linvatec biomaterial
K032447
4/16/2004
111
osteo acl screw model
linvatec biomaterial
K032894
5/7/2004
112
linvatec 10k irrigation system
linvatec corp.
K033573
2/11/2004
113
spineassist device
mazor surgical techn
K033413
1/7/2004
114
medi-stim veriq system, model vq1001 - v
medi-stim a/s
K040228
4/29/2004
115
liquishield liquid bandage, model lsb 00
medlogic global limi
K031321
1/21/2004
116
modification to cd horizon spinal system
medtronic sofamor da
K040072
2/12/2004
117
verte-stack spinal system
medtronic sofamor da
K040167
2/18/2004
118
arrowhead spinal system
medtronic sofamor da
K032560
3/9/2004
119
modification to verte-stack
medtronic sofamor da
K040422
3/19/2004
120
modification to: cd horizon spinal system
medtronic sofamor da
K040583
3/31/2004
121
modification to cd horizon spinal system
medtronic sofamor da
K034056
4/21/2004
122
modification to verte-stack spinal system
medtronic sofamor da
K040536
5/5/2004
123
modification to cd horizon spinal system
medtronic sofamor da
K040962
5/14/2004
124
modification to cd horizon spinal system
medtronic sofamor da
K041118
5/28/2004
125
modification to bone graft washer
medtronic sofamor da
K041217
5/28/2004
126
biocryl rapide interference screw
mitek worldwide
K032717
3/31/2004
127
cliploc soft tissue marker 18G/100MM (4"
mri devices corp.
K033447
1/28/2004
128
nsi hexed and non-hexed implant system a
northern implants, l
K033171
4/27/2004
129
perioglas-bioglass bone graft substitute
novabone products, l
K040278
3/1/2004
130
novabone-bbg-resorbable bone graft substitute
novabone products, l
K033994
3/25/2004
131
osteosorb tack fixation system
noviace corporation
K030989
4/1/2004
132
nuvasive neurovision jjb system
nuvasive, inc.
K040543
4/1/2004
133
nuvasive spinal system
nuvasive, inc.
K033546
4/12/2004
134
the gnathometer
ortho gnathics
llc
K033092
4/21/2004
135
odi talon long proximal femoral nail system
orthopedic designs,
K033286
1/12/2004
136
oti alumina ceramic femoral head system
osteoimplant technol
K040225
5/6/2004
137
osteomed orthodontic screw system
osteomed l.p.
K031936
1/7/2004
138
posterior cable screw
pioneer
surgical tec
K022908
1/22/2004
139
promos shoulder
plus
orthopedics
K032126
1/8/2004
140
modification to: the margron hip replace
portland orthopaedic
K032641
1/20/2004
141
quantum cement restrictor
quantum
orthopedics
K040276
4/30/2004
142
ellys and aurys vertebral body replacement
scient'x
K033109
3/23/2004
143
biofill bone void filler
scient'x
K040454
5/7/2004
144
anterior lumbar buttress system
seaspine
K040130
3/26/2004
145
modification to jet-x ha coated half pin
smith &
nephew, inc.
K033289
1/13/2004
146
trigen intertan
smith &
nephew, inc.
K040212
2/20/2004
147
smith & nephew electrothermal 20S spine
smith &
nephew, inc.
K033981
2/25/2004
148
smith & nephew rf denervation probes & r
smith &
nephew, inc.
K034012
3/16/2004
149
trigen trochanteric antegrade nail
smith &
nephew, inc.
K040462
3/23/2004
150
smith and nephew titanium interference s
smith &
nephew, inc.
K040331
4/14/2004
151
versabond ab bone cement
smith &
nephew, inc.
K022688
4/29/2004
152
modification to smith & nephew intramedu
smith &
nephew, inc.
K040656
5/25/2004
153
trigen adolescent tan
smith &
nephew, inc.
K040929
5/25/2004
154
spinal concepts inc. cadence and traxis
spinal
concepts, inc
K033517
2/18/2004
155
spinal concepts inc. coda
spinal
concepts, inc
K033663
5/27/2004
156
shiraz-java spinal fixation system
spine next america
K033772
1/27/2004
157
shiraz posterior system
spine next america
K033947
3/4/2004
158
shiraz-anterior system
spine next america
K033965
3/4/2004
159
plus pivot link universal system
spinevision,
inc.
K033508
1/27/2004
160
durex play lubricant
ssl americas, inc.
K032124
1/16/2004
161
colorado microdissec needle
stryker corp.
K033232
2/25/2004
162
stryker t4 hytrel zipper toga
stryker corp.
K040764
4/27/2004
163
simplex x
stryker corp.
K032945
5/25/2004
164
stryker consolidated operating room equipment
stryker
instruments
K032303
1/16/2004
165
stryker consolidated operating room equipment
stryker
instruments
K040300
3/3/2004
166
stryker rf electrodes and cannulae
stryker
instruments
K032406
4/1/2004
167
stryker consolidated operating room equipment
stryker
instruments
K040369
4/1/2004
168
stryker leibinger universal distal radiu
stryker
leibinger
K040022
3/12/2004
169
trident "t" acetabul
stryker
orthopaedics
K040412
5/25/2004
170
reflex hybrid anterior cervical plate sy
stryker spine
K040261
4/16/2004
171
synthes (usa) lcp dynamic helical hip sy
synthes (usa)
K033556
1/13/2004
172
synthes (usa) retrograde/antegrade femor
synthes (usa)
K033618
2/5/2004
173
synthes anterior cervical compression sy
synthes (usa)
K033844
2/5/2004
174
synthes (usa) 3.5 / 4.5 mm lcp metaphyse
synthes (usa)
K033805
2/20/2004
175
synthes (usa) craniofacial plates
synthes (usa)
K040272
2/23/2004
176
synthes 2.4 mm titanium (TI.) locking sc
synthes (usa)
K033975
3/1/2004
177
3.5 mm lcp distal humerus system
synthes (usa)
K033995
3/1/2004
178
synthes (usa) modification to sternal re
synthes (usa)
K033816
3/2/2004
179
synthes ventrofix mis system
synthes (usa)
K031100
3/4/2004
180
synthes medium external fixation system
synthes (usa)
K040258
3/23/2004
181
synthes external midface distractor
synthes (usa)
K040083
3/31/2004
182
synthes (usa) lateral entry femoral nail
synthes (usa)
K040336
4/12/2004
183
synthes (usa) tibial nail system ex
synthes (usa)
K040762
4/12/2004
184
synthes 5.0/7.3 mm cannulated locking sc
synthes (usa)
K040765
4/12/2004
185
synthes mandible external fixator
synthes (usa)
K040169
4/14/2004
186
synthes (usa) 2.4 mm lcp wrist plate
synthes (usa)
K040588
5/7/2004
187
synthes afs
synthes spine
K032534
4/1/2004
188
thermofocus 0800, 0900, 01500 and 0700 s
tecnimed
s.r.l.
K033790
6/3/2004
189
ceraform bone void filler
teknimed sa
K040669
5/3/2004
190
ceramic tipped skull pin
the jerome
group, in
K040363
4/12/2004
191
theken cpod/lpod vertebral body replacement
theken
surgical,llc
K032064
2/20/2004
192
stryker intervention pain rf generator
valley forge
scienti
K032601
4/1/2004
193
vertebron pss pedicle screw system
vertebron,
inc.
K033352
2/25/2004
194
vertebron scp cervical plate system
vertebron,
inc.
K040003
3/26/2004
195
arthoscopy pump a115
w.o.m. world
of medi
K033927
1/15/2004
196
advance double high insert
wright medical
techn
K033890
1/15/2004
197
evolve radial plate
wright medical
techn
K033456
1/28/2004
198
allomatrix model# 86
wright medical
techn
K020895
3/5/2004
199
ath femoral stem
wright medical
techn
K034028
3/11/2004
200
osteoset dbm pellets, model 8600-48XX
wright medical
techn
K022828
4/2/2004
201
profemur tapered hip stem
wright medical
techn
K041114
5/28/2004
202
zimmer unicompartmental knee system
zimmer, inc.
K033363
1/16/2004
203
minimally invasive solutions osteotomy g
zimmer, inc.
K033652
2/4/2004
204
zimmer ortho guidance systems- knee inst
zimmer, inc.
K033011
2/12/2004
205
zimmer ortho guidance systems- hip instr
zimmer, inc.
K033223
2/18/2004
206
periarticular locking plates and screws
zimmer, inc.
K040593
4/12/2004
207
ms-30 femoral stem standard and lateral
zimmer, inc.
K040803
4/29/2004
208
coonrad/morrey elbow cement restrictor
zimmer, inc.
K040389
5/17/2004
PMA APPROVALS
Orthopedic Device Name
Category
Approv.Date
INFUSE' Bone Graft
Bone Graft
4/30/2004
PRECISION
Spinal Cord Stimulator (SCS) System
Spinal,
Stimulator
4/27/2004
Hylaform
Skin
Fillers
4/22/2004
Oxford'
Meniscal Unicompartmental Knee System
Knee
Prostheses
4/21/2004
OP-1
Putty
Spinal,
Spinal Fusion
4/7/2004
Orthovisc'
High Molecular Weight Hyaluronan
Sodium
Hyaluronate
2/4/2004
2003 Orthopedic Device
Approvals
CoSeal'
Surgical Sealant
Sealants
12/12/2003
Keramos'
Ceramic/Ceramic Total Hip System
Hip
Prostheses
11/26/2003
Medtronic
Activa' Dystonia Therapy
Stimulator
4/15/2003
Ceramic
TRANSCEND' Hip Articulation System
Hip
Prostheses
2/3/2003
Osteonics'
ABC System and Trident' System
Hip
Prostheses
2/3/2003
2002 Orthopedic Device
Approvals
Siemens
SONOCUR' Basic
Elbow,
Extracorporeal, Shock Wave Therapy
7/19/2002
InFUSE'
Bone Graft/LT-CAGE' Lumbar Tapered Fusion Device
Back
Pain, Bone Graft Substitute, Spinal Fusion
7/2/2002
AFFINITY'
Cage System
Orthopedic
6/13/2002
Indermil'
Tissue Adhesive
Glue
5/22/2002
INTEGRA'
Dermal Regeneration Template
Burns,
Collagen, Dermal, Skin
4/19/2002
2001 Orthopedic Device
Approvals
CoSealTM
Surgical Sealant
Sealants
12/14/2001
BioGlue
Surgical Adhesive
Glue
12/3/2001
Ascension
MCP
Finger
Joint Implant, Orthopedic
11/19/2001
OP-1
TM Implant
Bone
Implant, Collagen
10/17/2001
Avanta
Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis
Finger
Joint Implant, Prostheses
8/28/2001
UBIS
5000 Ultrasound Bone Sonometer
Bone
Sonometers, Orthopedic, Ultrasound
7/17/2001
BAK/Cervical
(BAK/C) Interbody Fusion System
Orthopedic,
Spinal Fusion
4/20/2001
PROSTALAC
Hip Temporary Prosthesis
Hip
Prostheses
3/23/2001
TMJ
Fossa Eminence Prosthesis
Jaw
Surgery, Temporomandibular Joint, Temporomandibular Joint (TMJ) Implants
2/27/2001
SUPARTZ
Dispo
Sodium
Hyaluronate
1/24/2001
TMJ
(Temporomandibular Joint) Metal-on-Metal Total Joint Replacement Prostheses System
Temporomandibular
Joint (TMJ) Implants
1/5/2001
2000 Orthopedic Device
Approvals
OssaTron
Orthopedic,
Shock Wave Therapy
10/12/2000
DTU-One
Ultrasound Scanner
Bone
Sonometers
9/19/2000
QUS-2
Calcaneal Ultrasonometer
Bone
Sonometers
8/8/2000
CoStasis/DynaStat
Surgical Hemostat
Hemostat
6/13/2000
Stocker
70 RF Generator
Cardiac
Ablation Devices, Radiofrequency Ablation
5/31/2000
FocalSeal-Synthetic
Absorbable Sealant
Sealants
5/26/2000
