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)
3recalls in 12 months (299 all time)
269recalls that name a 510(k)
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Top companies in LPH

Company510(k)sRecalls
Zimmer GmbH4656
Biomet, Inc.4443
DePuy Orthopaedics, Inc.3323
Zimmer Biomet148
Howmedica Osteonics1631
Exactech, Inc.1926
Smith & Nephew, Inc.324
Depuy, Inc.240
Encore Medical L.P.1311
Howmedica Corp.180
DateFirm and productCodeLinked 510(k)
May 30, 2018Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00
Terminated		 LPHK063251
May 30, 2018Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 6; 00-7713-006-00
Terminated		 LPHK063251
May 30, 2018Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 5; 00-7713-005-00
Terminated		 LPHNone listed
May 30, 2018Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
Terminated		 LPHNone listed
May 30, 2018Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
Terminated		 LPHK060040
May 18, 2018OMNIlife science Inc.
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip repla
Terminated		 LPHK101976
Apr 2, 2018Zimmer Biomet, Inc.
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who
Terminated		 LPHK032396
Mar 14, 2018Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Terminated		 LPHK060040
Mar 14, 2018Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
Terminated		 LPHK032726
Jan 3, 2018Zimmer Biomet, Inc.
Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681
Terminated		 LPHK051491
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT R
Terminated		 LPHK030079
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Terminated		 LPHK030079
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Terminated		 LPHK033034
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Terminated		 LPHK973714
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Terminated		 LPHK973714
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Terminated		 LPHK973714
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Terminated		 LPHK973714
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Terminated		 LPHK973714
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Terminated		 LPHK030079
Nov 29, 2017Zimmer Biomet, Inc.
VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Terminated		 LPHK030079
Aug 1, 2017Zimmer Biomet, Inc.
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY
Terminated		 LPHK953337
K973714
Jul 21, 2017Howmedica Osteonics Corp.
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Terminated		 LPHK121308
K143085
Jul 21, 2017Howmedica Osteonics Corp.
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Terminated		 LPHK121308
K143085
Jun 29, 2017Zimmer Biomet, Inc.
PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revisi
Terminated		 LPHK093235
Mar 20, 2017Zimmer Biomet, Inc.
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 LPHK031572
Mar 20, 2017Zimmer Biomet, Inc.
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 LPHK031572
Mar 20, 2017Zimmer Biomet, Inc.
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 LPHK953337
Mar 20, 2017Zimmer Biomet, Inc.
Por fullct fem st 18x200mm, Sterile,
Terminated		 LPHK953337
Mar 20, 2017Zimmer Biomet, Inc.
Por fullct fem st 17x200mm, Sterile,
Terminated		 LPHK953337
Mar 20, 2017Zimmer Biomet, Inc.
Por fullct fem st 16x200mm, Sterile,
Terminated		 LPHK953337
Mar 20, 2017Zimmer Biomet, Inc.
Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants
Terminated		 LPHK953337
Mar 13, 2017CORENTEC CO., LTD
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Terminated		 LPHK162127
Dec 19, 2016Zimmer Biomet, Inc.
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Terminated		 LPHK110555
Dec 19, 2016Zimmer Biomet, Inc.
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
Terminated		 LPHK110555
Nov 7, 2016Exactech, Inc.
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Terminated		 LPHK993082
Jul 19, 2016Encore Medical, Lp
MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Terminated		 LPHK974294
Jun 3, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Terminated		 LPHK151264
May 16, 2016Zimmer Manufacturing B.V.
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x
Terminated		 LPHK934765
Apr 15, 2016Zimmer Trabecular Metal Technology, Inc.
00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0
Terminated		 LPHK964509
K980486
Mar 12, 2016Zimmer Manufacturing B.V.
Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 6200046
Terminated		 LPHK934765
Mar 12, 2016Zimmer Manufacturing B.V.
Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty
Terminated		 LPHK953490
Mar 12, 2016Zimmer Manufacturing B.V.
Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004
Terminated		 LPHK934765
Mar 12, 2016Zimmer Manufacturing B.V.
Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM
Terminated		 LPHK953337
Mar 12, 2016Zimmer Manufacturing B.V.
Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 2348005
Terminated		 LPHK934765
Mar 12, 2016Zimmer Manufacturing B.V.
Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 62500
Terminated		 LPHK934765
Mar 12, 2016Zimmer Manufacturing B.V.
Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FE
Terminated		 LPHNone listed
Feb 22, 2016Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement fo
Terminated		 LPHK953337
Feb 22, 2016Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, os
Terminated		 LPHK973714
Feb 22, 2016Zimmer Biomet, Inc.
VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, os
Terminated		 LPHK030079
Feb 22, 2016Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, os
Terminated		 LPHK042776

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