FDA.reportPublic FDA data

Echo® Bi-Metric® Microplasty® Hip Stem

Primary DI
00887868469848
Brand
Echo® Bi-Metric® Microplasty® Hip Stem
Company
Biomet Orthopedics, LLC
Model
110025760
Catalog number
110025760
Published
2022-06-22
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
OQHHip, semi-constrained, cemented, metal/polymer + additive, cemented
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
PBIprosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2
OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2
PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143009000Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.2014-12-18LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868469848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868469848008878684698488878684698480887868469848

GMDN Terms#

Term, Definition table
TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844017309NAimplantcast GmbHOQI2026-06-02
04048844708443EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711597EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711726EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711740EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711795EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711870EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711917EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711955EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711979EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712020EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712068EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712099EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712723NAimplantcast GmbHOQI2026-06-02
04048844712747NAimplantcast GmbHOQI2026-06-02
04048844712761NAimplantcast GmbHOQI2026-06-02
04048844712785NAimplantcast GmbHOQI2026-06-02
04048844712808NAimplantcast GmbHOQI2026-06-02
04048844712822NAimplantcast GmbHOQI2026-06-02
04048844712846NAimplantcast GmbHOQI2026-06-02
04048844712860NAimplantcast GmbHOQI2026-06-02
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01