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)
Top companies in MEH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIDENT 0 POLY INSERT 28mm ID
620-00-28D
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MEH | K983502 |
| Oct 21, 2025 | Theken 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 |
MEH | K191297 K241875 |
| Aug 11, 2022 | Exactech, 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 |
MEH | K040613 |
| Jul 28, 2021 | Corin 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 |
MEH | None listed |
| Jul 28, 2021 | Corin 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 |
MEH | None listed |
| Jul 28, 2021 | Corin 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 |
MEH | None listed |
| Jul 28, 2021 | Corin Ltd Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile. Terminated |
MEH | K082525 |
| Jul 28, 2021 | Corin 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 |
MEH | K170359 |
| Jul 28, 2021 | Corin 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 |
MEH | None listed |
| Jul 28, 2021 | Corin 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 |
MEH | K111481 |
| Jul 28, 2021 | Corin 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 |
MEH | K123705 |
| Jul 28, 2021 | Corin 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 |
MEH | K093472 |
| Jul 28, 2021 | Corin Ltd Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. Terminated |
MEH | K121563 |
| May 6, 2021 | Corin Ltd Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component. Terminated |
MEH | None listed |
| May 6, 2021 | Corin Ltd Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component. Terminated |
MEH | None listed |
| Apr 20, 2021 | Signature Orthopedics Pty Limited Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant. Terminated |
MEH | K121297 |
| Jan 25, 2021 | Corin 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 |
MEH | K130343 |
| Jan 25, 2021 | Corin 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 |
MEH | K130343 |
| Dec 17, 2020 | Biomet, 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 |
MEH | K051569 |
| Oct 9, 2019 | Signature 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 |
MEH | K161155 |
| Dec 4, 2018 | Waldemar 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 |
MEH | K171273 |
| Dec 4, 2018 | Waldemar 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 |
MEH | K171273 |
| Feb 2, 2018 | Signature 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 |
MEH | K121297 |
| Jan 18, 2018 | Exactech, 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 |
MEH | K162732 |
| Nov 21, 2016 | Depuy 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 |
MEH | K150862 |
| Nov 15, 2016 | Smith & 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 |
MEH | K072417 K080625 |
| Nov 15, 2016 | Smith & 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 |
MEH | K081124 K113789 |
| Nov 15, 2016 | Smith & 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 |
MEH | K121627 |
| Jul 28, 2016 | Smith & 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 |
MEH | K990666 |
| Nov 2, 2015 | Exactech, Inc. Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation Terminated |
MEH | K080980 |
| Feb 20, 2015 | Zimmer 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 |
MEH | K954800 |
| Feb 3, 2015 | Stryker 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 |
MEH | K983382 |
| Apr 2, 2014 | Stryker 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 |
MEH | K993768 |
| Feb 23, 2013 | Medacta 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 |
MEH | K083116 |
| Feb 7, 2013 | Medacta 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 |
MEH | K072857 K082792 +3 |
| Feb 4, 2013 | Zimmer, 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 |
MEH | K980711 |
| Jan 8, 2013 | Stryker 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 |
MEH | K994366 |
| Sep 20, 2012 | Smith & 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 |
MEH | K081124 |
| Jul 26, 2012 | Stryker 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 |
MEH | K092561 |
| Jul 26, 2012 | Stryker 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 |
MEH | K092406 |
| May 29, 2012 | Stryker 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 |
MEH | K951671 |
| Jan 30, 2012 | Stryker 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 |
MEH | K112556 |
| Oct 20, 2011 | Stryker 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 |
MEH | K994366 |
| Jun 30, 2011 | Medacta 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 |
MEH | K083116 |
| Feb 7, 2011 | Stryker 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 |
MEH | K912654 |
| Feb 7, 2011 | Stryker 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 |
MEH | K912654 |
| Feb 7, 2011 | Stryker 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 |
MEH | K912654 |
| Feb 7, 2011 | Stryker 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 |
MEH | K912654 |
| Feb 7, 2011 | Stryker 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 |
MEH | K912654 |
| Feb 7, 2011 | Stryker 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 |
MEH | K912654 |
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