Company · US
Corin USA
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2026. Name variants (Inc, Corp, punctuation) are merged.
82510(k) clearances (2 in 12 months)
24recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 32 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 20 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 12 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 |
| LLZ | System, Image Processing, Radiological | 6 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 3 |
| HWC | Screw, Fixation, Bone | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 |
| FCW | Light Source, Fiberoptic, Routine | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| HTN | Washer, Bolt Nut | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2026 | K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur Corin, Ltd., GB | MBH |
| Aug 10, 2026 | K261576 | Icona Hip Stem Corin, Ltd., GB | MEH |
| Jun 5, 2025 | K242744 | Trinity EVO Acetabular Shell Corin U.S.A. Limited | LPH |
| Jan 7, 2025 | K241808 | ApolloHipX (THR.SS.0001) Corin U.S.A. Limited | LLZ |
| Oct 3, 2024 | K241472 | Icona Hip Stem Corin U.S.A. Limited | MEH |
| Sep 23, 2024 | K241570 | Unity Total Knee System Corin U.S.A. Limited | JWH |
| Jun 26, 2024 | K240875 | Unity Knee PS-C Tibial Insert Corin U.S.A. Limited | JWH |
| Jul 26, 2023 | K231172 | ApolloKnee Corin U.S.A. Limited | OLO |
| Apr 7, 2022 | K212069 | Corin MetaFix Hip Stem Corin U.S.A. Limited | LZO |
| Jul 28, 2021 | K201657 | Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and Corin, Ltd. | LZO |
| Apr 12, 2021 | K203751 | OMNIVision system Corin USA | OLO |
| Nov 20, 2020 | K202805 | Optimized Positioning System (OPS) Insight Corin USA | LLZ |
| Aug 4, 2020 | K193545 | Corin Optimized Positioning System (OPS) Femoral Corin USA | LZO |
| Jun 27, 2020 | K200888 | OMNIBotics Knee System Corin, Ltd. | OLO |
| Jun 26, 2020 | K193042 | Optimized Positioning System (OPS) ReView Corin USA | LLZ |
| May 1, 2020 | K192656 | Optimized Positioning System (OPS) Insight Corin USA | LLZ |
| Jan 16, 2020 | K191831 | MobiliT Cup Corin U.S.A. Limited | LZO |
| Nov 4, 2019 | K190143 | LARS AC Band Device Corin USA | HTN |
| Jul 22, 2019 | K191374 | Revival Modular Hip Stem Corin U.S.A. Limited | LZO |
| Jul 22, 2019 | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) Corin USA | LZO |
| Jun 5, 2019 | K183114 | Corin BiPolar-i Corin U.S.A. Limited | KWY |
| Jun 4, 2019 | K183533 | Unity Total Knee System Corin U.S.A. Limited | JWH |
| Nov 26, 2018 | K183038 | Corin Optimized Positioning System (OPS) Plan Corin USA | LLZ |
| Sep 7, 2018 | K181061 | Corin Optimized Positioning System (OPS) Femoral Corin USA | LZO |
| Jun 15, 2018 | K172551 | Trinity PLUS Acetabular Shell Corin U.S.A. Limited | LPH |
| Apr 11, 2018 | K173880 | Corin TriFit CF Hip Stem Corin U.S.A. Limited | MEH |
| Apr 5, 2018 | K171847 | Corin Optimized Positioning System (OPS) Plan Corin U.S.A. Limited | LLZ |
| Jan 17, 2018 | K173884 | Unity Total Knee System Corin U.S.A. Limited | JWH |
| Oct 31, 2017 | K170359 | Trinity Dual Mobility System Corin U.S.A. Limited | LZO |
| Jul 13, 2017 | K170808 | Unity Total Knee System Corin U.S.A. Limited | JWH |
| Jun 20, 2017 | K162942 | Corin MetaFix Hip Stem Corin U.S.A. Limited | LZO |
| Jun 3, 2016 | K152893 | Corin Optimized Positioning System (OPS) Corin USA | LZO |
| Apr 29, 2016 | K152903 | REVIVAL(TM) Modular Revision Hip Stem Corin USA | LZO |
| Mar 31, 2016 | K153772 | Corin TriFit TS Hip Corin U.S.A. Limited | MEH |
| Mar 25, 2016 | K153725 | Corin TaperFit Hip Stem Corin U.S.A. Limited | JDI |
| Jan 21, 2016 | K153381 | Corin Metafix Hip Stem Corin U.S.A. Limited | LZO |
| Apr 3, 2015 | K142761 | Corin TaperFit Hip Stem Corin USA | JDI |
| Dec 16, 2013 | K131986 | CORIN MINIHIP STEM Corin USA | LZO |
| Dec 16, 2013 | K131952 | CORIN METAFIX HIP STEM Corin USA | LZO |
| Sep 27, 2013 | K131647 | TRINITY ACETABULAR SYSTEM Corin USA | LZO |
| May 28, 2013 | K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS Corin USA | LZO |
| May 24, 2013 | K130634 | CORIN METAFIX HIP STEM Corin USA | LZO |
| Feb 12, 2013 | K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS Corin USA | LZO |
| Nov 21, 2012 | K122305 | CORIN TRINITY-I ACETABULAR SHELL Corin USA | LZO |
| Oct 5, 2012 | K121563 | CORIN TRIFIT TS HIP Corin USA | MEH |
| Sep 14, 2012 | K121439 | METAFIX FEMORAL HIP STEM SIZE 1 Corin USA | LZO |
| Sep 10, 2012 | K113060 | UNITY TOATAL KNEE SYSTEM Corin USA | JWH |
| May 4, 2012 | K120362 | METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY Corin USA | LZO |
| Feb 6, 2012 | K111481 | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS Corin USA | OQI |
| Aug 4, 2011 | K111911 | CORIN OPTIMOM MODULAR HEAD Corin USA | KWL |
Newest 50 of 82.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2023 | Corin Ltd Unity Total Knee System, Model Number 112.001.34.
Primary and revision total knee arthroplasty Open, Classified |
JWH | K113060 |
| Nov 2, 2023 | Corin Ltd Unity CR Femur Right, Size 6, Model Number 112.001.32
Primary and revision total knee arthroplasty Open, Classified |
JWH | K113060 |
| Dec 19, 2022 | Corin Ltd Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 Open, Classified |
LZO | None listed |
| Dec 19, 2022 | Corin Ltd Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 Open, Classified |
LZO | None listed |
| Nov 21, 2022 | Corin Ltd Unity Total Knee System.
Used for knee prosthesis in total knee replacement Terminated |
JWH | K113060 |
| Jul 22, 2022 | Corin Ltd Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103 Open, Classified |
JDI | K082525 K153381 |
| Jul 12, 2022 | Corin Ltd TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component. Terminated |
JDI | K142761 |
| 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 |
| 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 |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular Shell
Product Usage Total Hip Replacement. Terminated |
LZO | K123705 |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular Shell
Product Usage: Total Hip Replacement. Terminated |
LZO | K123705 |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular System
Product Usage - Total Hip Replacement. Terminated |
LZO | K123705 |