Atlas FDA

Stryker CMF MEDPOR Priority Customized Implant Kit

FDA 510(k) clearance K191916 · decided 2019-08-15

Clearance details

K-number
K191916
Device name
Stryker CMF MEDPOR Priority Customized Implant Kit
Applicant
Stryker Leibinger GmbH & Co KG
Decision
Substantially Equivalent
Date received
2019-07-17
Decision date
2019-08-15
Days to decision
29 days
Clearance type
Special
Product code
FWP
Device class
2
Regulation number
878.3550
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Freiburg, DE
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MEDPOR Customized Implant Kit (K254233)Stryker Leibinger GmbH & Co KG2026-03-12
FITme Customized Silicone Implant (K232593)Keosan Trading Co.2023-11-22
Customized Contour Implant (K200610)Implantech Associates, Inc.2020-12-23
Customized Contour Implant (K191130)Implantech Associates, Inc.2019-08-23
Stryker CMF MEDPOR Customized Implant (K153508)Stryker2016-02-05
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (K152463)Poriferous, LLC2016-01-20
Stryker CMF MEDPOR Customized Implant (K143173)Stryker2015-03-23
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP (K141027)Implantech Associates, Inc.2014-07-10
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (K121315)Howmedica Osteonics Corp.2012-11-01
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (K091011)Surgical Technology Laboratories, Inc ("Stl")2009-04-22
AART CHIN IMPLANT (K021417)Aesthetic and Reconstructive Technologies, Inc.2002-07-02
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL (K012350)Porex Surgical, Inc.2002-03-14

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Adherus AutoSpray Dural Sealant (P130014/S021)Stryker Leibinger GmbH & Co KG2025-11-06
TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System (P980052/S016)Stryker Leibinger, GmbH & Co KG2025-07-23
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S020)Stryker Leibinger GmbH & Co KG2024-08-29
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S015)Stryker Leibinger, GmbH & Co KG2024-08-08
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S014)Stryker Leibinger, GmbH & Co KG2024-07-30
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S019)Stryker Leibinger GmbH & Co KG2023-10-07
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S018)Stryker Leibinger GmbH & Co KG2023-08-25
TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st (P980052/S012)Stryker Leibinger, GmbH & Co KG2023-08-22