FDA.reportPublic FDA data

TORNIER PERFORM™ HUMERAL SYSTEM

Primary DI
00846832082568
Brand
TORNIER PERFORM™ HUMERAL SYSTEM
Company
TORNIER, INC.
Model
MWX3PS
Catalog number
MWX3PS
Published
2022-04-07
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
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832082568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832082568008468320825688468320825680846832082568

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. 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(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840338607515Made-To-Order902706990270692026-04-28
00840338604033Tornier HRSARS10252ARS102522025-11-18
00840338604040Tornier HRSARS10253ARS102532025-11-18
00846832068678AEQUALIS™ FLEX REVIVE™ARS742301ARS7423012019-03-04
00846832068685AEQUALIS™ FLEX REVIVE™ARS742302ARS7423022019-03-04
00846832068692AEQUALIS™ FLEX REVIVE™ARS742303ARS7423032019-03-05
00846832068708AEQUALIS™ FLEX REVIVE™ARS742304ARS7423042019-03-04
00846832068715AEQUALIS™ FLEX REVIVE™ARS742305ARS7423052019-03-04
00846832068722AEQUALIS™ FLEX REVIVE™ARS742306ARS7423062019-03-04
00846832068739AEQUALIS™ FLEX REVIVE™ARS742401ARS7424012019-03-04
00846832068746AEQUALIS™ FLEX REVIVE™ARS742402ARS7424022019-03-04
00846832068777AEQUALIS™ FLEX REVIVE™ARS742405ARS7424052019-03-04
00846832068784AEQUALIS™ FLEX REVIVE™ARS742406ARS7424062019-03-04
00846832068814AEQUALIS™ FLEX REVIVE™ARS742501ARS7425012019-03-04
00846832068821AEQUALIS™ FLEX REVIVE™ARS742502ARS7425022019-03-04
00846832068838AEQUALIS™ FLEX REVIVE™ARS742503ARS7425032019-03-04
00846832068845AEQUALIS™ FLEX REVIVE™ARS742504ARS7425042019-03-04
00846832068852AEQUALIS™ FLEX REVIVE™ARS742505ARS7425052019-03-04
00846832068869AEQUALIS™ FLEX REVIVE™ARS742506ARS7425062019-03-04
00846832006588Futura™ FGTFGT-202015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648532EquinoxeExactech, Inc.KWT2026-03-19
10885862650429EquinoxeExactech, Inc.KWT2026-03-19
08033390272797SMR SystemLIMACORPORATE SPAKWT2026-02-25
08033390272803SMR SystemLIMACORPORATE SPAKWT2026-02-25
08033390272810SMR SystemLIMACORPORATE SPAKWT2026-02-25
10885862657046CSBExactech, Inc.KWT2026-01-28
10885862657053CSBExactech, Inc.KWT2026-01-28
B1132L1S0400020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0600020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0600030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0800020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0800030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1000020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1000030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1200020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1200030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L2HB000020Shoulder Innovations InSet 135 Instrument Case/TrayShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB000030Shoulder Innovations InSet 185 Instrument Case/TrayShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235040Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235060Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235080Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235100Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235120Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285060Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285080Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285100Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285120Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135010Shoulder Innovations InSet 135 Impaction Stand TowerShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135020Shoulder Innovations InSet 135/185 Impaction Stand BaseShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135030Shoulder Innovations InSet 135/185 Adjustable FootShoulder Innovations, Inc.KWT2025-12-12