← Product Code [MEH](/productcode/MEH) · K261576 # Icona Hip Stem (K261576) _Corin, Ltd. · MEH · Aug 10, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K261576 ## Device Facts - **Applicant:** Corin, Ltd. - **Product Code:** [MEH](/productcode/MEH.md) - **Decision Date:** Aug 10, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The indications for the Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union and femoral neck fractures - Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH) The Corin Icona Hip Stem is indicated for cementless use only. ## Device Story Tapered femoral hip stem; titanium alloy (Ti6Al4V) substrate; plasma-sprayed titanium and calcium phosphate coatings; trapezoidal triple-tapered body for rotational/axial stability; polished neck with 12/14 male trunnion. Used in total hip arthroplasty or hemiarthroplasty; implanted by orthopedic surgeons in clinical settings. Provides mechanical support for hip joint articulation; replaces damaged bone; restores mobility; reduces pain. Compatible with various Corin acetabular and femoral head components. Size 0 variant added to existing product line. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing including distal stem fatigue (ISO 7206-4), neck fatigue (ISO 7206-6), coating characterization, range of motion (ISO 21535), impingement, femoral head disassembly, corrosion, and MRI safety engineering rationales. ## Technological Characteristics Titanium alloy (Ti6Al4V) (ASTM F136) substrate; commercially pure titanium (ISO 5832-2, ASTM F1580) plasma spray; electrochemically deposited calcium phosphate (ASTM F1609) coating. Triple-tapered geometry; 12/14 male trunnion; collared. Cementless fixation. Available in 26 size/offset configurations. ## Regulatory Identification A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement. ## Predicate Devices - Icona Hip Stem ([K241472](/device/K241472.md)) - Actis DuoFix Hip Prosthesis ([K160907](/device/K160907.md)) ## Reference Devices - Trinity ([K093472](/device/K093472.md), [K103120](/device/K103120.md), [K110087](/device/K110087.md), [K111481](/device/K111481.md), [K122305](/device/K122305.md), [K123705](/device/K123705.md), [K130128](/device/K130128.md), [K130343](/device/K130343.md), [K131647](/device/K131647.md)) - Trinity PLUS ([K172551](/device/K172551.md)) - Trinity EVO ([K242744](/device/K242744.md)) - Trinity Dual Mobility ([K170359](/device/K170359.md)) - MobiliT ([K191831](/device/K191831.md)) - Bipolar-i ([K183114](/device/K183114.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 10, 2026 Corin, Ltd. Aaron Brunt Regulatory Affairs Manager The Corinium Centre Cirencester, Gloucestershire GL7 1YJ United Kingdom Re: K261576 Trade/Device Name: Icona Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, KWL, KWY, LZO Dated: May 8, 2026 Received: May 12, 2026 Dear Aaron Brunt: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261576 - Aaron Brunt Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K261576 - Aaron Brunt Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # LIMIN SUN -S Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K261576 Device Name Icona Hip Stem Indications for Use (Describe) The indications for the Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union and femoral neck fractures - Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH) The Corin Icona Hip Stem is indicated for cementless use only. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K261576 Page 1 of 3 Corin Connected Orthopaedic Insight 510(k) Notification Submission Icona Hip Stem # 510(K) SUMMARY 6 August 2026 # 1. CONTACT DETAILS Applicant Name: Corin, Ltd Applicant Address: The Corinium Centre, Cirencester, Gloucestershire, GL7 1YJ, United Kingdom Applicant Telephone: +44 07970237346 Applicant Contact: Aaron Brunt Applicant Email: aaron.brunt@coringroup.com # 2. DEVICE NAME Device Trade Name: Icona Hip Stem Common Name: Femoral Stem Classification: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulation Number: 888.3353 Product Code(s): MEH, KWL, KWY, LZO # 3. LEGALLY MARKETED PREDICATES | Predicate 510(k) | Predicate Trade Name | | --- | --- | | K241472 | Icona Hip Stem | | K160907 | Actis DuoFix Hip Prosthesis | # 4. DEVICE DESCRIPTION SUMMARY The Corin Icona Hip Stem is a tapered stem design manufactured from Titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2, ASTM F1580) and an additional layer of electrochemically deposited calcium phosphate (ASTM F1609) applied. The Icona Hip Stem is intended for use in hemiarthroplasty and total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components. The design is a fully-coated titanium femoral hip stem featuring a polished neck with 12/14 tapered male trunnion for assembly with Corin modular femoral head components. Additionally, the Icona stem features a trapezoidal, tripled tapered body, providing for rotational and axial stability. The Icona Hip Stem is compatible with the following acetabular and femoral systems/components: - Traditional – Trinity (K093472, K103120, K110087, K111481, K122305, K123705, K130128, K130343, K131647), Trinity PLUS (K172551) and Trinity EVO (K242744) - Dual mobility – Trinity Dual Mobility (K170359) and MobiliT (K191831) - Bipolar – Bipolar-i (K183114) {5} K261576 Page 2 of 3 Corin Connected Orthopaedic Insight 510(k) Notification Submission Icona Hip Stem The Icona Hip Stem is a collared stem available in two different offsets (Standard and Lateralised) and thirteen (13) different sizes, totaling 26 options. ## 5. INTENDED USE/INDICATIONS FOR USE The indications for the Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis • Rheumatoid arthritis • Correction of functional deformity • Treatment of non-union and femoral neck fractures • Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH) The Corin Icona Hip Stem is indicated for cementless use only. ## 6. INDICATIONS FOR USE COMPARISON The Icona Hip Stem (Size 0 variant) is identical to the Icona Hip Stem (K241472) in terms of intended use and indications. The Icona Hip Stem is similar to the additional predicate Actis Duofix Hip Prosthesis (K160907) in terms of intended use and indications with only changes in wording. ## 7. TECHNOLOGICAL COMPARISON The Icona Hip Stem Size 0 is identical to the primary predicate Icona Hip Stem (K241472) in all below categories: - Materials (titanium alloy (Ti6Al4V), titanium plasma spray coating (TPS) and calcium phosphate coating) - Design features (12/14 taper, threaded introducer feature, collar, coated regions) - Cementless fixation The main differences identified to the primary predicate is: • Size range (Inclusion of Size 0 stem) - Design features - Neck length, stem length, neck offset (due to size difference) The additional size 0 Icona Hip Stem is similar to the Size 0 additional predicate Actis Duofix Hip Prosthesis (K160907) in terms of design, with similar triple-taper geometry and a contoured reduced distal width. The Icona Hip Stem neck design is also very similar to Actis including a polished quadrangular shape, very similar CCD angle in two neck offsets, and similar leg and neck length ranges. The medial collar design is also very similar between Icona and Actis. {6} K261576 Page 3 of 3 Corin Connected Orthopaedic Insight 510(k) Notification Submission Icona Hip Stem ### 8. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS Non-clinical testing conducted to determine substantial equivalence includes: - Distal stem fatigue testing (ISO 7206-4) - Neck fatigue testing (ISO 7206-6) - Coating characterization rationale - Range of Motion (ROM) (ISO 21535) engineering rationale - Impingement performance engineering rationale - Femoral head disassembly performance engineering rationale - Corrosion performance engineering rationale - MRI Safety engineering rationale No clinical tests were performed to support the safety and effectiveness of the subject device. The results of the specific mechanical testing performed on the Icona Hip Stem show that the device is substantially equivalent to the predicate devices. A comparison of intended use and indications for use also demonstrated substantial equivalence. --- **Source:** [https://fda.innolitics.com/device/K261576](https://fda.innolitics.com/device/K261576) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com