Orthopaedic Devices 510(k Clearances - October 2013


The following companies received FDA 510(k) device clearance in October 2013:

CompanyDevice Name510(k) Number
aap ImplantateLoqteq proximal medial tibial plate 3.5K132554
Accel SpineCezanne II interbody fusion systemK131981
AcumedPolaris Connect humeral componentK131636
Aesculap (B Braun)Plasmafit acetabular cup and Vitelene insertK122783
AesculapUnivation unicondylar knee implantK131167
Altus PartnersAltus spine pedicle screw systemK132280
Anchor Innovation MedicalA.I.M. Suture anchorK132461
ArthrexUnivers II total shoulder system headsK130675
Beijing Libeir Bio-EngineeringLocking plate systemK132642
Biomedical ENTSmooth or threaded metallic bone fastenerK131640
BiometComprehensive reverse shoulder - titanium glenosphereK131353
BiometDistal radius volar rim plate (standard and narrow)K132704
BiometBiolox Delta ceramic femoral headK131684
BiometNo-profile screws; no-profile washers; no-profile Washerloc washersK122437
BiometMAK OSS femoral knee componentsK131393
Biomet2.5mm inline fusion plateK131867
BioProInfinity plate anchor systemK132510
Carbofix OrthopedicsPiccolo composite nailing systemK132774
CareFusionAVAflex vertebral balloon systemK131824
CareFusionAVAmax vertebral balloon systemK131820
ClarianceIdys lumbar interbody fusion cageK131178
Elite Surgical SuppliesBiolign anterior cervical interbody fusion (ACIF) system; Biolign Stacc ACIF system; Biolign thoracolumbar interbody fusion systemK130274
Ellipse TechnologiesPrecice intramedullary limb lengthening systemK131677
Encore MedicalReverse shoulder prosthesis monoblockK130048
Flower OrthopedicsFlower bone screw setK132248
ImplanetImplanet spine systemK132303
Innovative Surgical DesignsTrue spinal fixation systemK130958
Intelligent Implant SystemsMarauder cervicothoracic spinal fixation systemK132900
K2MEverest spinal systemK132361
Life SpineNautilus spinal systemK132760
Life SpinePresidio anterior lumbar plate systemK132589
Life SpineNautilus spinal systemK132866
Medacta GroupMpact DM acetabular liner converterK131458
MedicreaPass LP spinal systemK132575
MedtronicMagnifuse bone graft; Magnifuse II bone graftK131673
MedtronicCD Horizon spinal systemK132471
Nexxt SpineInertia minimally invasive pedicle screw systemK132412
NuVasiveGSB (global spinal balance) systemK132014
OMNI life scienceApex Knee modular tibia systemK131472
Ortho Development CorporationKnee system high-flex vitamin E posterior stabilisation tibial and patella insertsK131337
Ortho DevelopmentOvation 10/12 hip stemK131022
Pipeline OrthopedicsNeo knee systemK131368
Pivot MedicalCinchlock knotless suture anchor; Nanotack suture anchor 1.4mmK131769
SI-BONEiFuse implant systemK131405
Smith & NephewPolarstem standard and lateral femoral stems with titanium/hydroxyapatiteK130728
Smith & NephewDyonics plan hip impingement planning systemK132636
Smith & NephewGlobal femoral head trialsK132435
Solana SurgicalLesser metatarsal head implant systemK131187
Spectrum SpineFenestrated facet screw systemK132126
Spinal ElementsLotus posterior cervicothoracic fixation systemK131427
Spine WaveStaxx interbody fusion device with bone graftK132719
StrykerT2 tibial nailing systemK131365
StrykerUniversal Neuro III cranial bone flap fixation systemK131775
StrykerVariax II distal radius locking plate systemK132502
Synthes (DePuy Synthes, Johnson & Johnson)2.7 and 3.5mm variable angle LCP midfoot/hindfoot systemK131186
TornierAequalis shoulder fracture system; Aequalis reversed shoulder prosthesis; Aequalis reversed fracture shoulder prosthesisK131231
United Orthopedics CorporationU2 total knee system - PSA type, offset stem adapterK131116
Wright Medical GroupEvolution MP adaptive posterior stabilisation tibial insertK131679
X-spine SystemsCalix lumbar spinal implant systemK131350
This article is tagged to:
Sector: Medical Devices
Geography: United States

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