510(k) K182468

Device: Trident X3 Acetabular Inserts, ADM And MDM X3 Acetabular Inserts, Accolade II Hip System
Applicant: Howmedica Osteonics Corp Aka Stryker Orthopaedics
510(k) number: K182468
Product code: LPH
Decision: Substantially Equivalent (SESE)
Decision date: 2019-03-19
Date received: 2018-09-10
Regulation: 888.3358
Classification name: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Shahrir Alam
Address: 325 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers#

3007539489
3006536454
2242737
1836357
1828464
1526534
1818910
3002807314
3002806603
2528981
3003541440
1000517406
3012425419
3020162561
1721676
1720929
3011015572
3008421730
3010039400
1424263
3006128100
3004748528
3024890263
9614209
9681465
3003477135
3010531069
3007311878
3009973336
9611390
3004371426
9616671
1833986
3005551626
3002806470
3036773273
2249615
2648920
3014833750
3004635447
9616680
3033509898
1822565
3006946276
3014273644
1825034
3020155054
3043543260
3010388970
3010178296
1225675
9610726
1226188
1834379
3003595343
3007420745
3007740680
3004513872
1833920
3000258338
3009732568
3004153240
3007923096
1054811
1038671
3035366890
2183744
1000550978
3005751028
3008544874
1220477
3008556682
2134470
1057425
3015516266
3000264985
3014315560
3007200272
2245304
3005913274

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
07613327339697	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339123	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327338843	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327338867	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327338898	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327338928	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327338997	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339000	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339048	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339062	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339086	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339222	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327338799	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339666	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339635	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339543	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339444	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339437	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339390	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339314	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327339260	Trident X3 Insert	Howmedica Osteonics Corp.	2019-12-10
07613327341478	Trident X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327341461	Trident X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327341430	Trident X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327341416	Trident X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327316032	Restoration ADM X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327316025	Restoration ADM X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327316018	Restoration ADM X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327315998	Restoration ADM/MDM X3 Insert	Howmedica Osteonics Corp.	2019-11-12
07613327315813	Restoration ADM/MDM X3 Insert	Howmedica Osteonics Corp.	2019-11-12

Other 510(k) Records For Product Code LPH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K243192	iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating	Nextstep Arthopedix, LLC	2026-06-05
K251270	Taperloc® Complete Hip Stem	Biomet, Inc.	2026-05-19
K252623	G7® Revision Acetabular System	Zimmer, Inc.	2026-02-04
K251043	Mpact 3D Metal Implants Extension – DMLS Technology	Medacta International S.A.	2026-01-28
K252067	Velora Acetabular System	Restor3D, Inc.	2025-12-05
K252846	TaperSet™ Hip System	Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics	2025-11-20
K251833	EMPOWR Acetabular® Liner Extension	Encore Medical L.P.	2025-11-12
K251718	ArTT Augments and Buttresses and Bone Screws	Lima Corporate S.P.A.	2025-08-29
K250989	Stryker and Serf hip devices	Howmedica Osteonics Corp (Dba Stryker Orthopaedics)	2025-07-25
K243456	ONVOY™ Acetabular System	Globus Medical, Inc.	2025-06-06
K242744	Trinity EVO Acetabular Shell	Corin U.S.A. Limited	2025-06-05
K242232	Mpact 3D Metal Augments II	Medacta International S.A.	2025-04-23
K242045	Initia T3 Acetabular Hemispherical Shell System	Kyocera Medical Technologies, Inc.	2025-04-10
K243784	Stryker Orthopaedics Hip Devices Labeling Update	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025-02-06
K243977	EMPHASYS Acetabular System	Depuy Ireland UC	2025-01-22

510(k) K182468

Related Records#

Applicant Contact#

FDA Registration Numbers#

Source Documents#

Related GUDID Devices#

Other 510(k) Records For Product Code LPH #