FDA.reportPublic FDA data

XT Revision Ankle Replacement System

Primary DI
00885556828090
Brand
XT Revision Ankle Replacement System
Company
Smith & Nephew, Inc.
Model
MJV551T
Catalog number
MJV551T
Device description
INTEGRA XT. INSERT SPACER
Published
2022-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556828090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556828090008855568280908855568280900885556828090

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
20885556628908NavioPFSDV0016PFSDV00162016-09-21
00885556820964General InstrumentsMA3511NDMA3511ND2023-10-27
00885556822722Capture High Torque Screw SystemMAT-000-02MAT-000-022022-12-21
00885556822937Total Foot System 23210103210102022-12-21
00885556822944Total Foot System 23210123210122022-12-21
00885556832431Salto Talaris Total Ankle ProsthesisMJU012TMJU012T2022-12-21
00885556837825Total Foot System 23820003820002022-12-22
00885556840375Total Wrist Fusion System3035113035112022-12-21
00885556841525XT Revision Ankle Replacement SystemMJU944TMJU944T2022-12-21
00885556855003Freedom Wrist Arthroplasty System3480593480592022-12-22
00885556858301PyroCarbon PIP Total Joint SystemOSG-200-00OSG-200-002022-12-22
00885556858325PyroCarbon PIP Total Joint SystemOSG-200-10PVOSG-200-10PV2022-12-22
00885556858349PyroCarbon PIP Total Joint SystemOSG-200-20PVOSG-200-20PV2022-12-22
00885556858363PyroCarbon PIP Total Joint SystemOSG-200-30PVOSG-200-30PV2022-12-22
00885556858387PyroCarbon PIP Total Joint SystemOSG-200-40PVOSG-200-40PV2022-12-22
00885556861141Titan Modular Shoulder System 2.5MAL-0920-085-01MAL-0920-085-012022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327697209PANGEAStryker GmbHLXH2026-08-27
00840606185950ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185967ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186414ALIFSPINAL ELEMENTS, INC.LXH2026-08-26