FDA.report

Osteotomy guide, reusable

Definition
A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.
GUDID devices
1,553
Last updated
2026-03-27 18:10:10

Related Product Codes

CodeDeviceSpecialtyClassDevices
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2453
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1385
LXHOrthopedic Manual Surgical InstrumentOrthopedic1375
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic294
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic241
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic241
HRSPlate, Fixation, BoneOrthopedic226
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery124
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic220
HWTTemplateOrthopedic115
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic213
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic211
OYKAnkle Arthroplasty Implantation SystemOrthopedic210
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic28
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic28
OLOOrthopedic Stereotaxic InstrumentNeurology26
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic25
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic24
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic24
LHXTrousers, Anti-ShockCardiovascular23
NDPAccessories, Implant, Dental, EndosseousDental13
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedOrthopedic22
HTHProtractorOrthopedic11
HTJGauge, DepthOrthopedic11
HTOReamerOrthopedic11
HTWBit, DrillOrthopedic11
JRYAntiserum, Fluorescent, Epstein-Barr VirusMicrobiology11
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic21
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic21
SAIAnkle Fusion CageOrthopedic21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
10885862660688N/AExactech, Inc.161-00-022026-03-19
10885862661227N/AExactech, Inc.163-00-012026-03-19
10885862661296N/AExactech, Inc.165-00-052026-03-19
04719886912562U2 Total Knee SystemUNITED ORTHOPEDIC CORP.9303-2255-TF2026-02-23
04719886912579U2 Total Knee SystemUNITED ORTHOPEDIC CORP.9303-2260-TF2026-02-23
00822409133147N/AOrtho Development CorporationC-18562026-02-05
00846832078745PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX1002020-11-10
00846832078752PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX1012020-11-10
00846832078769PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX1352020-11-10
00846832078783PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX0112020-11-10
00846832078790PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX0122020-11-10
00846832078806PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX0132020-11-10
00846832078813PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX0142020-11-10
00846832079025PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWX0102020-11-10
00843575128416Mobio™ Specialty B-ONE ORTHO, CORP.8829P050022026-02-13
00843575128423Mobio™ Specialty B-ONE ORTHO, CORP.8829P050032026-02-13
00843575128430Mobio™ Specialty B-ONE ORTHO, CORP.8829P050042026-02-13
00843575128447Mobio™ Specialty B-ONE ORTHO, CORP.8829P050052026-02-13
00843575128454Mobio™ Specialty B-ONE ORTHO, CORP.8829P050062026-02-13
00843575128461Mobio™ Specialty B-ONE ORTHO, CORP.8829P050072026-02-13
00843575128478Mobio™ Specialty B-ONE ORTHO, CORP.8829P050082026-02-13
00843575128485Mobio™ Specialty B-ONE ORTHO, CORP.8829P050092026-02-13
00843575128492Mobio™ Specialty B-ONE ORTHO, CORP.8829P050102026-02-13
00846832075065PERFORM™ HUMERAL SYSTEMTORNIER, INC.MWM0012020-11-10
00840338607720Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.MWJ2812026-01-21
00840338607737Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.MWJ2822026-01-21
00840338607744Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.MWJ2832026-01-21
00840338607775Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.MWJ2862026-01-21
00840338607782Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.MWJ2872026-01-21
00841731134486Hintermann Series VILEX LLCHT-390412026-01-20
00841731134493Hintermann Series VILEX LLCHT-390422026-01-20
00841731134509Hintermann Series VILEX LLCHT-390432026-01-20
00841731134516Hintermann Series VILEX LLCHT-390442026-01-20
00841731134523Hintermann Series VILEX LLCHT-390452026-01-20
00841731134530Hintermann Series VILEX LLCHT-390512026-01-20
00841731134547Hintermann Series VILEX LLCHT-390522026-01-20
00841731134554Hintermann Series VILEX LLCHT-390532026-01-20
00841731134561Hintermann Series VILEX LLCHT-390542026-01-20
00841731134578Hintermann Series VILEX LLCHT-390552026-01-20
00841731134707Hintermann Series VILEX LLCHT-397102026-01-16
00841731134714Hintermann Series VILEX LLCHT-397112026-01-16
00840097513263Ossera™ AFX InstrumentationRestor3d, Inc.5740-00022025-12-18
00841731126078Hintermann Series VILEX LLCHT-399532025-09-17
00841731126085Hintermann Series VILEX LLCHT-399542025-09-17
00841731126443Hintermann Series VILEX LLCHT-399602025-09-17
00841731126450Hintermann Series VILEX LLCHT-399612025-09-17
00841731126467Hintermann Series VILEX LLCHT-399622025-09-17
00841731126474Hintermann Series VILEX LLCHT-399632025-09-17
00841731126481Hintermann Series VILEX LLCHT-399642025-09-17
00841731126498Hintermann Series VILEX LLCHT-399652025-09-17
00841731126504Hintermann Series VILEX LLCHT-399662025-09-17
00841731126511Hintermann Series VILEX LLCHT-399702025-09-17
00841731126528Hintermann Series VILEX LLCHT-399712025-09-17
00841731126535Hintermann Series VILEX LLCHT-399722025-09-17
00841731126542Hintermann Series VILEX LLCHT-399732025-09-17
00841731126559Hintermann Series VILEX LLCHT-399742025-09-17
00841731126566Hintermann Series VILEX LLCHT-399752025-09-17
00841731126573Hintermann Series VILEX LLCHT-399762025-09-17
00841731134172Hintermann Series VILEX LLCHT-390142025-09-17
00841731134189Hintermann Series VILEX LLCHT-390132025-09-17
00841731134196Hintermann Series VILEX LLCHT-390122025-09-17
00841731134202Hintermann Series VILEX LLCHT-390152025-09-17
00841731134332Hintermann Series VILEX LLCHT-390202025-09-17
00841731134349Hintermann Series VILEX LLCHT-390212025-09-17
00841731134356Hintermann Series VILEX LLCHT-390222025-09-17
00841731134363Hintermann Series VILEX LLCHT-390232025-09-17
00841731134370Hintermann Series VILEX LLCHT-390242025-09-17
00841731134387Hintermann Series VILEX LLCHT-390252025-09-17
00841731134394Hintermann Series VILEX LLCHT-390262025-09-17
00841731134400Hintermann Series VILEX LLCHT-390302025-09-17
00841731134417Hintermann Series VILEX LLCHT-390312025-09-17
00841731134424Hintermann Series VILEX LLCHT-390322025-09-17
00841731134431Hintermann Series VILEX LLCHT-390332025-09-17
00841731134448Hintermann Series VILEX LLCHT-390342025-09-17
00841731134455Hintermann Series VILEX LLCHT-390352025-09-17
00841731134462Hintermann Series VILEX LLCHT-390362025-09-17
00841731134141Hintermann Series VILEX LLCHT-390092025-09-12
00841731134158Hintermann Series VILEX LLCHT-390082025-09-12
00841731134165Hintermann Series VILEX LLCHT-390072025-09-12
00841731134240Hintermann Series VILEX LLCHT-390112025-09-12