FDA.reportPublic FDA data

Vanguard XP® Instrumentation

Primary DI
00887868501128
Brand
Vanguard XP® Instrumentation
Company
Biomet Orthopedics, LLC
Model
32-700375
Catalog number
32-700375
Published
2021-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBVProsthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122160000VANGUARD XP KNEE SYSTEMBiomet Manufacturing Corp2013-03-20MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868501128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868501128008878685011288878685011280887868501128

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707726SolidLok®2810-01-0212810010212026-06-10
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161088World Knee CR TiN Cementless Femur - Size 2 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161095World Knee CR TiN Cementless Femur - Size 3 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161101World Knee CR TiN Cementless Femur - Size 4 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161118World Knee CR TiN Cementless Femur - Size 5 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161125World Knee CR TiN Cementless Femur - Size 6 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161132World Knee CR TiN Cementless Femur - Size 7 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161149World Knee CR TiN Cementless Femur - Size 8 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161156World Knee CR TiN Cementless Femur - Size 9 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161163World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161170World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161187World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161194World Knee Cementless Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161200World Knee Cementless Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161217World Knee Cementless Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161224World Knee Cementless Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161231World Knee Cementless Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161248World Knee Cementless Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161255World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161262World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161279World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161286World Knee Cementless Titanium Tibial Plate - Modular - Size 4 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26