ClearanceBrief
Panels › Orthopedic › Product code MEH · Class 2

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Regulation 888.3353

2510(k)s in 12 months (160 all time)
1recalls in 12 months (197 all time)
190recalls that name a 510(k)
Get daily alerts for MEHSample briefCSV

Top companies in MEH

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Howmedica Osteonics Corp.
TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
MEHK983502
Oct 21, 2025Theken Companies LLC
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm
Open, Classified
MEHK191297
K241875
Aug 11, 2022Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
Open, Classified
MEHK040613
Jul 28, 2021Corin Ltd
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
Terminated
MEHNone listed
Jul 28, 2021Corin Ltd
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243,
Terminated
MEHNone listed
Jul 28, 2021Corin Ltd
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
Terminated
MEHNone listed
Jul 28, 2021Corin Ltd
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
Terminated
MEHK082525
Jul 28, 2021Corin Ltd
Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity D
Terminated
MEHK170359
Jul 28, 2021Corin Ltd
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
Terminated
MEHNone listed
Jul 28, 2021Corin Ltd
Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.
Terminated
MEHK111481
Jul 28, 2021Corin Ltd
Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
Terminated
MEHK123705
Jul 28, 2021Corin Ltd
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are
Terminated
MEHK093472
Jul 28, 2021Corin Ltd
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Terminated
MEHK121563
May 6, 2021Corin Ltd
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
Terminated
MEHNone listed
May 6, 2021Corin Ltd
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Terminated
MEHNone listed
Apr 20, 2021Signature Orthopedics Pty Limited
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Terminated
MEHK121297
Jan 25, 2021Corin Ltd
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabul
Terminated
MEHK130343
Jan 25, 2021Corin Ltd
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetab
Terminated
MEHK130343
Dec 17, 2020Biomet, Inc.
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip,
Terminated
MEHK051569
Oct 9, 2019Signature Orthopaedics Europe Ltd
Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 008411
Open, Classified
MEHK161155
Dec 4, 2018Waldemar Link GmbH & Co. KG (Mfg Site)
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot
Terminated
MEHK171273
Dec 4, 2018Waldemar Link GmbH & Co. KG (Mfg Site)
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot
Terminated
MEHK171273
Feb 2, 2018Signature Orthopedics Pty Limited
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14
Terminated
MEHK121297
Jan 18, 2018Exactech, Inc.
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery
Terminated
MEHK162732
Nov 21, 2016Depuy Orthopaedics Inc.
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
Terminated
MEHK150862
Nov 15, 2016Smith & Nephew, Inc.
Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitat
Terminated
MEHK072417
K080625
Nov 15, 2016Smith & Nephew, Inc.
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilita
Terminated
MEHK081124
K113789
Nov 15, 2016Smith & Nephew, Inc.
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have fail
Terminated
MEHK121627
Jul 28, 2016Smith & Nephew, Inc.
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where ot
Terminated
MEHK990666
Nov 2, 2015Exactech, Inc.
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Terminated
MEHK080980
Feb 20, 2015Zimmer Gmbh
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degene
Terminated
MEHK954800
Feb 3, 2015Stryker Howmedica Osteonics Corp.
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) de
Terminated
MEHK983382
Apr 2, 2014Stryker Howmedica Osteonics Corp.
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hi
Terminated
MEHK993768
Feb 23, 2013Medacta Usa Inc
Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.2
Terminated
MEHK083116
Feb 7, 2013Medacta Usa Inc
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create
Terminated
MEHK072857
K082792 +3
Feb 4, 2013Zimmer, Inc.
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System i
Terminated
MEHK980711
Jan 8, 2013Stryker Howmedica Osteonics Corp.
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the hea
Terminated
MEHK994366
Sep 20, 2012Smith & Nephew Inc
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 F
Terminated
MEHK081124
Jul 26, 2012Stryker Howmedica Osteonics Corp.
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies
Open, Classified
MEHK092561
Jul 26, 2012Stryker Howmedica Osteonics Corp.
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is
Open, Classified
MEHK092406
May 29, 2012Stryker Howmedica Osteonics Corp.
Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA cementless Hip System is designed to address t
Terminated
MEHK951671
Jan 30, 2012Stryker Howmedica Osteonics Corp.
Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Product Usage: Orthopaedic implants utiliz
Terminated
MEHK112556
Oct 20, 2011Stryker Howmedica Osteonics Corp.
Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 A s
Terminated
MEHK994366
Jun 30, 2011Medacta Usa Inc
Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is designed for cement
Terminated
MEHK083116
Feb 7, 2011Stryker Howmedica Osteonics Corp.
Omnifit PSL M/S 3-Hole Cup, 58MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr
Terminated
MEHK912654
Feb 7, 2011Stryker Howmedica Osteonics Corp.
Omnifit PSL M/S 3-Hole Cup, 54MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr
Terminated
MEHK912654
Feb 7, 2011Stryker Howmedica Osteonics Corp.
Omnifit PSL M/S 3-Hole Cup, 50MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr
Terminated
MEHK912654
Feb 7, 2011Stryker Howmedica Osteonics Corp.
Omnifit PSL M/S 3-Hole Cup, 48MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr
Terminated
MEHK912654
Feb 7, 2011Stryker Howmedica Osteonics Corp.
Omnifit PSL M/S 3-Hole Cup, 46MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr
Terminated
MEHK912654
Feb 7, 2011Stryker Howmedica Osteonics Corp.
Omnifit M/S Dual Geom Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative art
Terminated
MEHK912654

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.