Data / Medical devices / United Kingdom / Corin Limited
Corin Limited: FDA-registered device maker in CIRENCESTER Gloucestershire, United Kingdom, 39 510(k) clearances
Corin Limited is registered with the FDA (registration 9614209) in CIRENCESTER Gloucestershire, United Kingdom. It lists 17 device types. The FDA files 39 510(k) clearances under its listings, the newest dated August 10, 2026. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614209
- FEI number
- 3002806725
- Address
- The Corinium Centre, CIRENCESTER Gloucestershire, United Kingdom, GL7 1YJ
- Owner or operator
- Corin Group (9012268)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 13, 2007
- Registered through
- 2026
- Brand names listed
- 1120109, 1120110, 1120111, 1120112, 1120114, 1120116, 1120118, 1120120 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 10, 2026 | K261576 | Icona Hip Stem | MEH | Substantially Equivalent | Corin, Ltd. | accessdata.fda.gov |
| June 5, 2025 | K242744 | Trinity EVO Acetabular Shell | LPH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| January 7, 2025 | K241808 | ApolloHipX (THR.SS.0001) | LLZ | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| October 3, 2024 | K241472 | Icona Hip Stem | MEH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| September 23, 2024 | K241570 | Unity Total Knee System | JWH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| June 26, 2024 | K240875 | Unity Knee PS-C Tibial Insert | JWH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| July 26, 2023 | K231172 | ApolloKnee | OLO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| April 7, 2022 | K212069 | Corin MetaFix Hip Stem | LZO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| January 16, 2020 | K191831 | MobiliT Cup | LZO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| June 5, 2019 | K183114 | Corin BiPolar-i | KWY | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| June 4, 2019 | K183533 | Unity Total Knee System | JWH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| June 15, 2018 | K172551 | Trinity PLUS Acetabular Shell | LPH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| April 11, 2018 | K173880 | Corin TriFit CF Hip Stem | MEH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| January 17, 2018 | K173884 | Unity Total Knee System | JWH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| October 31, 2017 | K170359 | Trinity Dual Mobility System | LZO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| July 13, 2017 | K170808 | Unity Total Knee System | JWH | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| January 21, 2016 | K153381 | Corin Metafix Hip Stem | LZO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| April 3, 2015 | K142761 | Corin TaperFit Hip Stem | JDI | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| September 27, 2013 | K131647 | TRINITY ACETABULAR SYSTEM | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| May 28, 2013 | K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| March 14, 2013 | K123782 | PARAGON HIP SYSTEM | LZO | Substantially Equivalent | Global Manufacturing Technology | accessdata.fda.gov |
| March 8, 2013 | K130128 | TRINITY ACETABULAR SYSTEM | LZO | Substantially Equivalent | Corin Medical | accessdata.fda.gov |
| February 12, 2013 | K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| November 21, 2012 | K122305 | CORIN TRINITY-I ACETABULAR SHELL | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| October 5, 2012 | K121563 | CORIN TRIFIT TS HIP | MEH | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| September 14, 2012 | K121439 | METAFIX FEMORAL HIP STEM SIZE 1 | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| September 10, 2012 | K113060 | UNITY TOATAL KNEE SYSTEM | JWH | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| February 6, 2012 | K111481 | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS | OQI | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| June 29, 2011 | K111046 | CORIN MINIHIP FEMORAL STEM | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| May 3, 2011 | K110087 | CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| March 9, 2011 | K103518 | TRINITY ACETABULAR SYSTEM | LWJ | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| February 28, 2011 | K103120 | CORIN BIOLOX DELTA FEMORAL HEADS | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| November 23, 2010 | K093472 | TRINITY ACETABULAR SYSTEM | MEH | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| April 5, 2010 | K083312 | MINIHIP STEM | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| February 4, 2010 | K082525 | CORIN METAFIX FEMORAL STEM | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| November 30, 2004 | K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | MMP | Substantially Equivalent | Guangzhou Fortunique , Ltd. | accessdata.fda.gov |
| February 8, 2001 | K003666 | TAPER-FIT TOTAL HIP SYSTEM | JDI | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| November 10, 1999 | K992234 | THE TAPER-FIT TOTAL HIP SYSTEM | JDG | Substantially Equivalent | Corin USA | accessdata.fda.gov |
| August 9, 1993 | K925897 | CORIN BIPOLAR PROSTHESIS | KWY | Substantially Equivalent | Corin Orthopedic Products | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 23, 2025 | 97006 | Class II | Ongoing | Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-5277 | Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. | accessdata.fda.gov |
| October 13, 2023 | 93144 | Class II | Ongoing | Unity CR Femur Right, Size 6, Model Number.32 Primary and revision total knee arthroplasty | Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa. | accessdata.fda.gov |
| November 8, 2022 | 91183 | Class II | Ongoing | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | accessdata.fda.gov |
| October 31, 2022 | 91039 | Class II | Terminated | Unity Total Knee System. Used for knee prosthesis in total knee replacement | The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging. | accessdata.fda.gov |
| July 22, 2022 | 90573 | Class II | Ongoing | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number | One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630. | accessdata.fda.gov |
| July 12, 2022 | 90662 | Class II | Terminated | TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + Centraliser, For Cemented Use, REF. Orthopedic hip implant component. | Some of the devices did not pass fatigue testing. | accessdata.fda.gov |
| July 28, 2021 | 88589 | Class II | Terminated | Corin TriFit TS, Size 8, Standard Tapered Stem, REF, Sterile. | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | accessdata.fda.gov |
| May 6, 2021 | 87959 | Class II | Terminated | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF. Hip prosthesis component. | Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa. | accessdata.fda.gov |
| January 25, 2021 | 87293 | Class II | Terminated | 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 Acetabular System is a modula | The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Hip, Femoral Component, Cemented, Metal
Updated August 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.