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) |
|---|---|---|---|
| Jul 22, 2021 | Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral 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 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. 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 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. 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 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component. Open, Classified |
LPH | K051556 |
| Dec 17, 2020 | Biomet, Inc. RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Const Terminated |
LPH | K063570 K082446 +3 |
| Dec 17, 2020 | Biomet, Inc. M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures. Terminated |
LPH | K031693 K945115 |
| Dec 17, 2020 | Biomet, Inc. Custom Cancellous Thread, Item numbers CP161941,
CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. C Terminated |
LPH | K991807 |
| Sep 21, 2020 | Conformis, Inc. iTotal Hip Replacement System, Model number HAA-050-D020-020102
The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral ste Terminated |
LPH | K192198 |
| Sep 9, 2020 | Encore Medical, LP EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatm Open, Classified |
LPH | K190057 |
| Aug 14, 2020 | Zimmer Biomet, Inc. Dual Mobility Vivacit-E Bearing, Model Number 110031009 Terminated |
LPH | K190656 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17) Terminated |
LPH | K151264 |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17) Terminated |
LPH | K151264 |
| Oct 22, 2019 | Encore Medical, LP EMPOWR Acetabular System, Non-Sterile, Model Numbers
803-15-023
803-15-026
803-15-027
803-15-028
803-15-029
803-15-030
Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joi Open, Classified |
LPH | K190057 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Hip Joint Replacement Systems, Item Nos. 00151504232
00151504432
00151504636
00151504836
00151505040
00151505240
00151505444
00151505644
00151505848
00151506048
00151506248
00151506448
0015150 Terminated |
LPH | K171858 K181630 +1 |
| Oct 3, 2019 | Howmedica Osteonics Corp. Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint
REF 0942-8-025 Terminated |
LPH | K121308 |
| Sep 11, 2019 | OMNIlife science Inc. OMNI Hip System
Model, Catalogue, or Order Number(s): HC-00070
Intended for use as the femoral component of a primary or revision total hip replacement. Terminated |
LPH | K060072 |
| Aug 22, 2019 | Conformis, Inc. iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right Terminated |
LPH | K162719 |
| Aug 22, 2019 | Conformis, Inc. iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right Terminated |
LPH | K162719 |
| Aug 21, 2019 | Zimmer Biomet, Inc. Various Hip systems, Item Nos. 104207
104212
104215
11-162809
11-162810
11-162811
11-162812
11-162813
21-103202
21-103203
21-103204
21-103205
21-103206
21-103207
21-103208
21-103209
21-103210
21-10321 Terminated |
LPH | K023409 K030055 |
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
ApeX-LNK crosslinked Acetabular Insert, 10 deg hood;
Product Code : H5-54840 Terminated |
LPH | K100555 |
| Mar 29, 2019 | Conformis, Inc. Conformis iTotal Hip Replacement System:
HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT) Terminated |
LPH | None listed |
| Mar 29, 2019 | Conformis, Inc. Conformis iTotal Hip Replacement System:
HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Terminated |
LPH | K162719 |
| Feb 19, 2019 | Smith & Nephew, Inc. smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511 Terminated |
LPH | K103256 |
| Feb 19, 2019 | Smith & Nephew, Inc. smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510 Terminated |
LPH | K103256 |
| Oct 16, 2018 | Conformis, Inc. iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 Terminated |
LPH | K162719 |
| Jul 10, 2018 | Encore Medical, LP djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the lab Open, Classified |
LPH | K120241 |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 9; 00-7713-009-00 Terminated |
LPH | K063251 |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 7.5; 00-7713-007-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 22.5; 00-7713-022-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 20; 00-7713-020-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 17.5; 00-7713-017-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 16.25; 00-7713-016-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 15; 00-7713-015-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 13.5; 00-7713-013-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 12.5; 00-7713-012-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 11; 00-7713-011-00 Terminated |
LPH | None listed |
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