Corin USA
Tampa, FL, US
Corin USA appears in FDA device records in Tampa, FL. FDA records list 78 510(k) clearances between and , 13 PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
Showing 50 of 78FDA records hold 78 510(k) clearances for Corin USA between 1996 and 2025. The busiest year on record is 2012, with 6. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 3 |
| 1997 | 5 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 4 |
| 2001 | 3 |
| 2002 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| 2010 | 4 |
| 2011 | 5 |
| 2012 | 6 |
| 2013 | 6 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242744 | Trinity EVO Acetabular Shell | LPH | Substantially Equivalent | |
| K241808 | ApolloHipX (THR.SS.0001) | LLZ | Substantially Equivalent | |
| K241472 | Icona Hip Stem | MEH | Substantially Equivalent | |
| K241570 | Unity Total Knee System | JWH | Substantially Equivalent | |
| K240875 | Unity Knee PS-C Tibial Insert | JWH | Substantially Equivalent | |
| K231172 | ApolloKnee | OLO | Substantially Equivalent | |
| K212069 | Corin MetaFix™ Hip Stem | LZO | Substantially Equivalent | |
| K203751 | OMNIVision system | OLO | Substantially Equivalent | |
| K202805 | Optimized Positioning System (OPS) Insight | LLZ | Substantially Equivalent | |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | LZO | Substantially Equivalent | |
| K193042 | Optimized Positioning System (OPS) ReView | LLZ | Substantially Equivalent | |
| K192656 | Optimized Positioning System (OPS) Insight | LLZ | Substantially Equivalent | |
| K191831 | MobiliT Cup | LZO | Substantially Equivalent | |
| K190143 | LARS AC Band Device | HTN | Substantially Equivalent | |
| K191374 | Revival Modular Hip Stem | LZO | Substantially Equivalent | |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | LZO | Substantially Equivalent | |
| K183114 | Corin BiPolar-i | KWY | Substantially Equivalent | |
| K183533 | Unity Total Knee System | JWH | Substantially Equivalent | |
| K183038 | Corin Optimized Positioning System (OPS) Plan | LLZ | Substantially Equivalent | |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | LZO | Substantially Equivalent | |
| K172551 | Trinity PLUS Acetabular Shell | LPH | Substantially Equivalent | |
| K173880 | Corin TriFit CF Hip Stem | MEH | Substantially Equivalent | |
| K171847 | Corin Optimized Positioning System (OPS™) Plan | LLZ | Substantially Equivalent | |
| K173884 | Unity Total Knee System | JWH | Substantially Equivalent | |
| K170359 | Trinity™ Dual Mobility System | LZO | Substantially Equivalent | |
| K170808 | Unity Total Knee System | JWH | Substantially Equivalent | |
| K162942 | Corin MetaFix Hip Stem | LZO | Substantially Equivalent | |
| K152893 | Corin Optimized Positioning System (OPS) | LZO | Substantially Equivalent | |
| K152903 | REVIVAL(TM) Modular Revision Hip Stem | LZO | Substantially Equivalent | |
| K153772 | Corin TriFit TS Hip | MEH | Substantially Equivalent | |
| K153725 | Corin TaperFit Hip Stem | JDI | Substantially Equivalent | |
| K153381 | Corin Metafix Hip Stem | LZO | Substantially Equivalent | |
| K142761 | Corin TaperFit Hip Stem | JDI | Substantially Equivalent | |
| K131986 | CORIN MINIHIP STEM | LZO | Substantially Equivalent | |
| K131952 | CORIN METAFIX HIP STEM | LZO | Substantially Equivalent | |
| K131647 | TRINITY ACETABULAR SYSTEM | LZO | Substantially Equivalent | |
| K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS | LZO | Substantially Equivalent | |
| K130634 | CORIN METAFIX HIP STEM | LZO | Substantially Equivalent | |
| K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS | LZO | Substantially Equivalent | |
| K122305 | CORIN TRINITY-I ACETABULAR SHELL | LZO | Substantially Equivalent | |
| K121563 | CORIN TRIFIT TS HIP | MEH | Substantially Equivalent | |
| K121439 | METAFIX FEMORAL HIP STEM SIZE 1 | LZO | Substantially Equivalent | |
| K113060 | UNITY TOATAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K120362 | METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY | LZO | Substantially Equivalent | |
| K111481 | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS | OQI | Substantially Equivalent | |
| K111911 | CORIN OPTIMOM MODULAR HEAD | KWL | Substantially Equivalent | |
| K111046 | CORIN MINIHIP FEMORAL STEM | LZO | Substantially Equivalent | |
| K110087 | CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS | LZO | Substantially Equivalent | |
| K103518 | TRINITY ACETABULAR SYSTEM | LWJ | Substantially Equivalent | |
| K103120 | CORIN BIOLOX DELTA FEMORAL HEADS | LZO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWQAppliance, Fixation, Spinal Intervertebral Body
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- GCJLaparoscope, General & Plastic Surgery
- GCTLight Source, Endoscope, Xenon Arc
- FCWLight Source, Fiberoptic, Routine
- OLOOrthopedic Stereotaxic Instrument
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KXAProsthesis, Hip, Femoral, Resurfacing
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HWCScrew, Fixation, Bone
- LLZSystem, Image Processing, Radiological
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1528-2016 | Trinity Acetabular Shell Product Usage Total Hip Replacement. | Potential for abrasion of the sterile barrier pouches of the new packaging system. | Class II | Terminated | |
| Z-1527-2016 | Trinity Acetabular Shell Product Usage: Total Hip Replacement. | Potential for abrasion of the sterile barrier pouches of the new packaging system. | Class II | Terminated | |
| Z-1526-2016 | Trinity Acetabular System Product Usage - Total Hip Replacement. | Potential for abrasion of the sterile barrier pouches of the new packaging system. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain