FDA.reportPublic FDA data

SYNERGY

Primary DI
03596010459695
Brand
SYNERGY
Company
Smith & Nephew, Inc.
Model
71309014
Catalog number
71309014
Device description
SYNERGY POROUS PLUS HA STANDARD OFFSET SIZE 14
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002996000
K090982000
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002996000SYNERGY HA COATED POROUS FEMORAL STEMSSmith & Nephew, Inc.2000-12-11MEH
K090982000SMITH & NEPHEW HIP SYSTEMS WITH HASmith & Nephew, Inc.2010-04-21MEH
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010459695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010459695035960104596953596010459695

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556918937NA72205810722058102026-08-19
00885556918968NA72205911722059112026-08-19
00885556919897NA72205802722058022026-08-19
00885556919965NA72205777722057772026-08-19
00885556919972NA72205778722057782026-08-19
00885556919989NA72205790722057902026-08-19
00885556919996NA72205791722057912026-08-19
00885556920008NA72205792722057922026-08-19
00885556920015NA72205793722057932026-08-19
00885556920022NA72205800722058002026-08-19
00885556920039NA72205801722058012026-08-19
00885556920046NA72205782722057822026-08-19
00885556920053NA72205803722058032026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUD72205781722057812026-08-14
00885556924440TESSA72205783722057832026-08-14
00885556924457TESSA72205784722057842026-08-14
00885556924464NA72205785722057852026-08-14
00885556926680TESSA72205786722057862026-08-14
00885556926703TESSA72205787722057872026-08-14
00885556922170NA74034437740344372026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
00192629031999LineageMicroport Orthopedics Inc.LPH2026-08-18
00192629080515MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629176553MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629031951MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629031968LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031975LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031982LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629163584MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176515MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176522MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176539MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176546MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14