FDA.reportPublic FDA data

PROPHECY INCOMPASS

Primary DI
00889797111126
Brand
PROPHECY INCOMPASS
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
33820305
Catalog number
33820305
Device description
Resect-Through Guide Insert
Published
2026-06-23
Public version status
New
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
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253159000Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)2026-06-16HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797111126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797111126008897971111268897971111260889797111126

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). 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)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00889797080392PRO-DENSE LoVisc87SRLV0587SRLV052023-11-21
00889797080415PRO-DENSE LoVisc87SRLV1087SRLV102023-11-21
00889797103589PRO-DENSE LoVisc87SRLV2087SRLV202023-11-21
00889797109796PRO-DENSE LoVisc1420LVGA1420LVGA2023-11-21
00889797076005MINI IGNITE 2.0876P0020876P00202022-08-23
00889797076012MINI IGNITE 2.0876P0040876P00402022-08-23
00889797076036IGNITE 2.0876P0200876P02002022-08-23
00889797076029IGNITE™ 2.0876P0080876P00802022-02-24
00889797072700PRO-DENSE™87SR015087SR01502020-09-08
00889797072717PRO-DENSE™87SR040087SR04002020-09-08
00889797072724PRO-DENSE™87SRCDK087SRCDK02020-09-08
00889797072748PRO-DENSE™87SR002087SR00202020-09-08
00889797072755PRO-DENSE™87SR005087SR00502020-09-08
00889797072762PRO-DENSE™87SR010087SR01002020-09-08
00889797073301PRO-DENSE™87SR007087SR00702020-09-08
00889797073318PRO-DENSE™87SR012087SR01202020-09-08
00840420133434OSTEOSET84000211840002112015-10-15
00840420133465OSTEOSET84000305840003052015-10-15
00840420133472OSTEOSET84000310840003102015-10-15
00840420133489OSTEOSET84000311840003112015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795150080APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151001APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151018APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151025APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151032APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151049APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151056APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151063APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151070APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151087APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151094APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151100APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151117APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151124APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151131APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151148APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151155APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151162APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151179APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151186APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151193APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151209APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151216APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151223APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151230APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12