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)
3recalls 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) |
|---|---|---|---|
| Feb 11, 2016 | Zimmer Biomet, Inc. M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 Terminated |
LPH | K032726 |
| Nov 10, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component. Terminated |
LPH | K121308 |
| Sep 23, 2015 | Stryker Howmedica Osteonics Corp. Trident 10 degrees X3 Insert 36 mm ID
Catalog #623-10-36I
Hip implant component Terminated |
LPH | K033716 |
| Aug 29, 2015 | Biomet, Inc. Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. Terminated |
LPH | K093235 |
| Aug 21, 2015 | Omnilife Science Inc. APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356.
Product Usage:
The Apex Interface Acetabular System is intended for use in combination with the Apex Mo Terminated |
LPH | K112779 |
| Jun 11, 2015 | Biomet, Inc. Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip j Terminated |
LPH | K003429 K030055 |
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
Hip prosthesis component. The RESTORATION Acet Terminated |
LPH | K102019 |
| Feb 20, 2015 | Zimmer Gmbh CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty. Terminated |
LPH | K993259 |
| Feb 17, 2015 | Biomet, Inc. Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc) Terminated |
LPH | K030055 |
| Dec 24, 2014 | Zimmer Manufacturing B.V. Trilogy Fiber Metal Acetabular Shell Size 54 mm OD
The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision sur Terminated |
LPH | K934765 |
| Dec 17, 2014 | Zimmer Manufacturing B.V. Bone Screw, self-tapping
The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional f Terminated |
LPH | K934765 |
| Oct 22, 2014 | Signal Medical Corporation Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20.
Device is intended for use with Whiteside Biomechanics, Inc./ Terminated |
LPH | K955271 |
| Jul 10, 2014 | Zimmer, Inc. Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5.
The femoral stem component of a modular system that consists of an acetabula Terminated |
LPH | None listed |
| Jul 10, 2014 | Zimmer, Inc. Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5.
The femoral stem component of a modular system that consists of an acetabul Terminated |
LPH | None listed |
| Jul 10, 2014 | Zimmer, Inc. Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular Terminated |
LPH | K032726 |
| Jun 20, 2014 | Zimmer, Inc. VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 Terminated |
LPH | K973714 |
| Apr 24, 2014 | Zimmer, Inc. TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component. Terminated |
LPH | K021891 |
| Mar 4, 2014 | Djo Surgical FMP X-alt Acetabular Liner
This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip. Terminated |
LPH | K072154 |
| Feb 20, 2014 | Zimmer, Inc. 6 DEGREE COCR FEM HEAD 36 Terminated |
LPH | K953337 |
| Feb 20, 2014 | Zimmer, Inc. 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) Terminated |
LPH | K953337 |
| Feb 20, 2014 | Zimmer, Inc. HGP II ACETABULAR CUP MOD Terminated |
LPH | K921308 |
| Feb 20, 2014 | Zimmer, Inc. TRILOGY ACET SHELL 36MM O
TRILOGY ACET SHELL 38MM O
TRILOGY ACET SHELL 40MM O
TRILOGY ACET SHELL 42MM O
TRILOGY ACET SHELL 44MM O
TRILOGY ACET SHELL 46MM O
TRILOGY ACET SHELL 48MM O
TRILOGY ACET SHELL Terminated |
LPH | K934765 K953490 +1 |
| Feb 20, 2014 | Zimmer, Inc. MODULAR CUP NEUTRAL LINER
MODULAR CUP 10 DEGREE LIN
MODULAR CUP 20 DEGREE LIN
MODULAR CUP 7MM OFFSET LI Terminated |
LPH | K043101 K872379 +3 |
| Feb 3, 2014 | Exactech, Inc. ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630.
The Exactech Novation InteGrip Acetabular Augments are indicated for use in Terminated |
LPH | K101761 K113609 |
| Dec 26, 2013 | Smith & Nephew Inc REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA.
Orthopaedic. Terminated |
LPH | K012787 |
| Oct 25, 2013 | Zimmer, Inc. CoCr Head (Not distributed in the United States)
Used in total hip replacement. Terminated |
LPH | None listed |
| Oct 25, 2013 | Zimmer, Inc. Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FE Terminated |
LPH | K953337 |
| Jun 5, 2013 | Biomet, Inc. Active Articulation E1.
Intended for use with either primary or revision hip arthroplasty. Terminated |
LPH | K101336 |
| May 24, 2013 | Orthopedic Alliance LLC Femoral head, standard, 26mm, +0mm
Femoral head,medium, 26mm,+3mm
Femoral head, long, 26mm, +6mm
Femoral head, X-long, 26mm, +9mm
Femoral head, 28mm, -3mm
Femoral head, 28mm, +0mm
Femoral head, 28mm, Terminated |
LPH | K111546 |
| May 24, 2013 | Orthopedic Alliance LLC U2 Acetabular cup, Ti beads porous coated, 44mm
U2 Acetabular cup, Ti beads porous coated, 46mm
U2 Acetabular cup, Ti beads porous coated, 48mm
U2 Acetabular cup, Ti beads porous coated, 50mm
U2 Aceta Terminated |
LPH | K121777 |
| May 22, 2013 | DePuy Orthopaedics, Inc. Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452
Product Usage:
An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to pro Terminated |
LPH | K102423 |
| Feb 4, 2013 | Zimmer, Inc. Trilogy Acetabular Shells with Holes.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | K934765 |
| Feb 4, 2013 | Zimmer, Inc. Trilogy Acetabular Shell with Cluster Holes.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | K934765 |
| Feb 4, 2013 | Zimmer, Inc. Trilogy Acetabular Shell Spiked.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | K934765 |
| Feb 4, 2013 | Zimmer, Inc. Trilogy F/M Acetabular Shell with Uni-Hole.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | K934765 |
| Feb 4, 2013 | Zimmer, Inc. Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM.
The Trilogy Acetabular System is indicated fo Terminated |
LPH | K934765 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS R 9IN CALC 2.25/22.5
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS R 9IN CALC 2.25/21
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added pro Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS R 9IN CALC 2.25/19.5
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS R 9IN CALC 2.25/18
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added pro Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS R 9IN CALC 2.25/16.5
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS R 9IN CALC 2.25/15.0
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS F 9 CALC L 13.5MM LG
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS L 9IN CALC 2.25/22.5
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS L 9IN CALC 2.25/21
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added pro Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS L 9IN CALC 2.25/19.5
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS L 9IN CALC 2.25/18
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added pro Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS L 9IN CALC 2.25/16.5
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS L 9IN CALC 2.25/15.0
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
| Dec 20, 2012 | DePuy Orthopaedics, Inc. SOL SYS F 9 CALC L 13.5MM LG
Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added p Terminated |
LPH | K060581 |
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