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)
Top companies in LPH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 46 | 56 |
| Biomet, Inc. | 44 | 43 |
| DePuy Orthopaedics, Inc. | 33 | 23 |
| Zimmer Biomet | 1 | 48 |
| Howmedica Osteonics | 16 | 31 |
| Exactech, Inc. | 19 | 26 |
| Smith & Nephew, Inc. | 32 | 4 |
| Depuy, Inc. | 24 | 0 |
| Encore Medical L.P. | 13 | 11 |
| Howmedica Corp. | 18 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Feb 2, 2026 | Encore 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 |
LPH | K190057 |
| Nov 3, 2025 | Zimmer, 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 |
LPH | K190656 |
| Nov 3, 2025 | Zimmer, 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 |
LPH | K190656 |
| Oct 14, 2025 | BioPro, 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 |
LPH | K895886 |
| Oct 14, 2025 | BioPro, 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 |
LPH | K090208 |
| Jul 21, 2025 | Encore 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 |
LPH | K203557 |
| Jul 21, 2025 | Encore 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 |
LPH | K203557 |
| Apr 15, 2025 | Conformis 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 |
LPH | K202484 |
| Feb 12, 2025 | Exactech, 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 |
LPH | K182502 |
| Nov 18, 2024 | Novosource, 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 |
LPH | K132158 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Apr 25, 2024 | Howmedica 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 |
LPH | K171768 |
| Jan 18, 2024 | Exactech, 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 |
LPH | K182502 |
| Oct 12, 2023 | Encore Medical, LP EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H Open, Classified |
LPH | K190057 |
| Sep 26, 2023 | Waldemar 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 |
LPH | K200607 |
| Mar 29, 2023 | Zimmer, 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 |
LPH | K993259 |
| Mar 23, 2023 | Biomet, Inc. G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462 Open, Classified |
LPH | K150522 |
| Oct 21, 2022 | Encore Medical, LP EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. Open, Classified |
LPH | K143242 |
| Oct 21, 2022 | Encore Medical, LP EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component. Open, Classified |
LPH | K190057 |
| Aug 11, 2022 | Exactech, 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 |
LPH | K100269 |
| Aug 11, 2022 | Exactech, 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 |
LPH | K051556 |
| Aug 11, 2022 | Exactech, 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 |
LPH | K041906 |
| Dec 21, 2021 | Howmedica Osteonics Corp. 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 Open, Classified |
LPH | K121308 |
| Oct 1, 2021 | OmniLife 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 |
LPH | K041950 |
| Oct 1, 2021 | Limacorporate 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 |
LPH | K172456 |
| Oct 1, 2021 | Limacorporate 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 |
LPH | K172456 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 K070479 +1 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 K070479 +1 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K100269 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K100269 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K070479 K121392 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 K070479 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 K070479 +1 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K070479 K100269 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K121392 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 K070479 +1 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 K070479 +1 |
| Jul 22, 2021 | Exactech, 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 |
LPH | K051556 K070479 |
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