FDA.reportPublic FDA data

HTR-PEKK

Primary DI
00810188325907
Brand
HTR-PEKK
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
PK627449
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161052000OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.2016-07-20KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810188325907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810188325907008101883259078101883259070810188325907

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made cranial bone prosthesisAn implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
904-741-4400fxjax-orders@biomet.com

Regulatory Flags#

DUNS number
962301359
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
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
00810188325945HTR-PEKKPK6274522026-10-19
00810188325884HTR-PEKKPK6274422026-10-14
00810188325891HTR-PEKKPK6274472026-10-14
00810188325853HTR-PEKKPK6274432026-10-13
00810188325563HTR-PEKKPK6274122026-10-12
00810188325815HTR-PEKKPK6274342026-10-12
00810188325860HTR-PEKKPK6274442026-10-12
00810188325877HTR-PEKKPK6274452026-10-12
00810188325846HTR-PEKKPK6274402026-10-09
00810188325785HTR-PEKKPK6274332026-10-08
00810188324801HTR-PEKKPK6273482026-10-07
00810188325761HTR-PEKKPK627048-A2026-10-07
00810188325617HTR-PEKKPK6274192026-10-06
00810188325778HTR-PEKKPK6274262026-10-06
00810188325716HTR-PEKKPK6274252026-10-05
00810188325792HTR-PEKKPK6274352026-10-05
00810188325808HTR-PEKKPK6274362026-10-05
00810188325709HTR-PEKKPK627388-A2026-09-30
00810188325600HTR-PEKKPK6274162026-09-29
00810188325655HTR-PEKKPK6274182026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324542HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-05-14
00810188323965HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188323972HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188322555HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810188322562HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810128537384HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2024-09-09
00810128531702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-08-08
00810128531795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-07-25
00810128530149HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810128530156HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810077249741HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-02-16
00810077249284HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-18
00810077248959HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-04
00810077247471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247488HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247518HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-08
00815285024180SU-POR Surgical ImplantPORIFEROUS, LLCKKY2022-08-01
00815285024197SU-POR Surgical ImplantPORIFEROUS, LLCKKY2022-08-01
00810077245828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-06-21
00810077245675HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-05-20
00810077244937HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-04-20
00810077243312HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-14
00810077242605HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-05
00810023928409HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2021-01-22
00810023927631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-11-09
00810023925477HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-06-23
00810023924920HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-04-30
00810023923589HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-02-24
00810023920984HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-20
00810023920854HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-15