ClearanceBrief
Panels › Orthopedic › Product code LPH · Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Regulation 888.3358

11510(k)s in 12 months (565 all time)
5recalls in 12 months (299 all time)
269recalls that name a 510(k)
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Top companies in LPH

DateFirm and productCodeLinked 510(k)
Oct 6, 2026Onkos Surgical, Inc.
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Open, Classified
LPHK212815
K223348
Oct 6, 2026Onkos Surgical, Inc.
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Open, Classified
LPHK212815
K223348
Feb 2, 2026Encore Medical, LP
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degr
Open, Classified
LPHK190057
Nov 3, 2025Zimmer, Inc.
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Open, Classified
LPHK190656
Nov 3, 2025Zimmer, Inc.
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Open, Classified
LPHK190656
Oct 14, 2025BioPro, Inc.
BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO
Open, Classified
LPHK895886
Oct 14, 2025BioPro, Inc.
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORA
Open, Classified
LPHK090208
Jul 21, 2025Encore Medical, LP
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mo
Open, Classified
LPHK203557
Jul 21, 2025Encore Medical, LP
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mo
Open, Classified
LPHK203557
Apr 15, 2025Conformis Inc.
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Open, Classified
LPHK202484
Feb 12, 2025Exactech, Inc.
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHX
Open, Classified
LPHK182502
Nov 18, 2024Novosource, LLC
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including fem
Open, Classified
LPHK132158
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Open, Classified
LPHK171768
Apr 25, 2024Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
Open, Classified
LPHK171768
Jan 18, 2024Exactech, Inc.
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Open, Classified
LPHK182502
Oct 12, 2023Encore Medical, LP
EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H
Open, Classified
LPHK190057
Sep 26, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Open, Classified
LPHK200607
Mar 29, 2023Zimmer, Inc.
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
Open, Classified
LPHK993259
Mar 23, 2023Biomet, Inc.
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Open, Classified
LPHK150522
Oct 21, 2022Encore Medical, LP
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Open, Classified
LPHK143242
Oct 21, 2022Encore Medical, LP
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Open, Classified
LPHK190057
Aug 11, 2022Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED L
Open, Classified
LPHK100269
Aug 11, 2022Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. AC
Open, Classified
LPHK051556
Aug 11, 2022Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, R
Open, Classified
LPHK041906
Dec 21, 2021Howmedica Osteonics Corp.
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Open, Classified
LPHK121308
Oct 1, 2021OmniLife Science
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for unceme
Terminated
LPHK041950
Oct 1, 2021Limacorporate S.p.A
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Terminated
LPHK172456
Oct 1, 2021Limacorporate S.p.A
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Terminated
LPHK172456
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation G
Open, Classified
LPHK051556
K070479 +1
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Nov
Open, Classified
LPHK051556
K070479 +1
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
Open, Classified
LPHK100269
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
Open, Classified
LPHK100269
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.
Open, Classified
LPHK051556
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip
Open, Classified
LPHK070479
K121392
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novati
Open, Classified
LPHK051556
K070479
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner,
Open, Classified
LPHK051556
K070479 +1
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic
Open, Classified
LPHK070479
K100269
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
Open, Classified
LPHK121392
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hi
Open, Classified
LPHK051556
K070479 +1
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hi
Open, Classified
LPHK051556
K070479 +1
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL
Open, Classified
LPHK051556
K070479

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