FDA.reportPublic FDA data

REDAPT

Primary DI
00885556338223
Brand
REDAPT
Company
Smith & Nephew, Inc.
Model
71354048
Catalog number
71354048
Device description
REDAPT MODULAR SLEEVE MEDIUM SIZE 26-27 STIKTITE WITH HYDROXYAPATITE
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121627000
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121627000SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEMSmith & Nephew, Inc.2012-10-15MEH
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556338223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556338223008855563382238855563382230885556338223

GMDN Terms#

Term, Definition table
TermDefinition
Sleeve femoral/tibial extension, coatedA sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032064LineageMicroport Orthopedics Inc.LZO2026-08-18
00192629032033LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032040LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032057LineageMicroport Orthopedics Inc.LZO2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19