The indications for the Corin 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 Description

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 a collared stem available in two different offsets (Standard and Lateralised) and twelve (12) different sizes, totaling 24 options.

The Icona Hip Stem is compatible with the following acetabular systems:

· Traditional – Trinity (K093472, K110087, K111481, K122305, K130128, K130343, K131647) and Trinity PLUS (K17255) · Dual mobility - Trinity Dual Mobility (K170359) and MobiliT (K191831)

· Bipolar - Bipolar-i (K183114)

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a hip stem device (Icona Hip Stem). It does not describe an AI/ML medical device, but rather a traditional medical device (hip implant). Therefore, much of the requested information regarding acceptance criteria and studies for AI/ML performance metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the relevant information regarding the traditional device's performance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Metric	Reported Device Performance / Compliance
Mechanical Performance	Distal stem fatigue (ISO 7206-4)	Results show the device is substantially equivalent to predicate devices.
	Neck fatigue (ISO 7206-6)	Results show the device is substantially equivalent to predicate devices.
	Range of motion (ROM) (ISO 21535)	Cadaveric evaluation demonstrated performance.
	Impingement performance	Engineering rationale provided.
	Femoral head disassembly and corrosion performance	Engineering rationale provided.
Biocompatibility	Material: Titanium alloy (Ti6Al4V) (ASTM F136), commercially pure titanium (ISO 5832-2, ASTM F1580), electrochemically deposited calcium phosphate (ASTM F1609)	Materials are industry standards and consistent with predicate devices, supporting biocompatibility by equivalence.
Indications for Use	Functional equivalence for: Non-inflammatory degenerative joint disease (osteoarthritis, 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). Indicated for cementless use only.	The Icona Hip Stem is "substantially equivalent" to predicate devices (Actis DuoFix, TriFit CF, Metafix, OMNI MOD Hip System) in terms of intended use and indications, with the exception of OMNI MOD Hip Stem which is also indicated for revision.
Design Equivalency	Tapered stem design, fully-coated titanium femoral hip stem, polished neck, 12/14 tapered male trunnion, trapezoidal triple tapered body, two offsets (Standard and Lateralised), twelve sizes (24 options).	Substantially equivalent to predicate devices Actis DuoFix Hip Prosthesis (K150862) (material, triple-taper geometry, collar design, stem sizes), TriFit CF (K173880) (material, coating, taper design, neck geometry), OMNI MOD Hip System (K000788, K201657) (material, neck geometry, finish), and MetaFix Hip Stem (K082525, K121439, K153381, K212069) (intended use, indications, material, neck geometry, taper design, packaging).

2. Sample Size Used for the Test Set and the Data Provenance

This information is typically not provided in detail within a 510(k) summary for mechanical testing of traditional orthopedic implants. The document states "Non-clinical testing and rationales provided to support substantial equivalence," but does not specify sample sizes for these mechanical tests (e.g., number of stems tested for fatigue).

Provenance: The tests are non-clinical (laboratory/mechanical testing), not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for a traditional orthopedic implant's mechanical testing or equivalence comparison to predicate devices. "Ground truth" in this context would refer to established engineering standards (ISO, ASTM) and the performance of predicate devices.

4. Adjudication Method

Not applicable for this type of device submission. Adjudication is relevant for expert review of data, often in clinical studies or for AI ground truth establishment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, this is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

No, this is not an AI/ML device.

7. The Type of Ground Truth Used

For this traditional device, the "ground truth" used to establish substantial equivalence is primarily:

Established engineering standards: ISO 7206-4, ISO 7206-6, ISO 21535, ASTM F136, ASTM F1580, ASTM F1609. The device's performance in these tests is compared against the performance of the predicate devices or the requirements of these standards.
Performance of legally marketed predicate devices: The Icona Hip Stem's design, materials, and mechanical performance are compared to those of already cleared predicate devices. Substantial equivalence implies that the new device performs as safely and effectively as the predicate.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device; there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 3, 2024

Corin USA Limited Aaron Brunt Senior Regulatory Affairs Specialist 12750 Citrus Park Lane Tampa, Florida 33625

Re: K241472

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 24, 2024 Received: September 6, 2024

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.

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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 System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory

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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

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Indications for Use

510(k) Number (if known) K241472

Device Name Icona Hip Stem

Indications for Use (Describe)

The indications for the Corin 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #: K241472		510(k) Summary	Prepared on: 2024-10-03
Contact Details			21 CFR 807.92(a)(1)
Applicant Name		Corin USA Limited
Applicant Address		12750 Citrus Park Lane Tampa FL 33625 United States
Applicant Contact Telephone		+4407970237346
Applicant Contact		Mr. Aaron Brunt
Applicant Contact Email		aaron.brunt@coringroup.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name		Icona Hip Stem
Common Name		Femoral Stem
Classification Name		Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis
Regulation Number		888.3353
Product Code(s)		MEH, KWL, KWY, LZO
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #		Predicate Trade Name (Primary Predicate is listed first)	Product Code
K150862	Actis DuoFix Hip Prosthesis		MEH
K173880	TriFit CF Hip Stem		MEH
K201657	OMNI MOD Hip System		LZO
K212069	Metafix Hip Stem		LZO
Device Description Summary			21 CFR 807.92(a)(4)
The Corin Icona Hip Stem is a tapered stem design manufactured from Titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commerciallypure 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 increasedmobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat andsupport the components.
The design is a fully-coated titanium femoral hip stem featuring a polished neck with 12/14 tapered male trunnion for assembly withCorin modular femoral head components. Additionally, the Icona stem features a trapezoidal, tripled tapered body, providing forrotational and axial stability.
The Icona Hip Stem is a collared stem available in two different offsets (Standard and Lateralised) and twelve (12) different sizes, totaling 24 options.

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The Icona Hip Stem is compatible with the following acetabular systems:

· Traditional – Trinity (K093472, K110087, K111481, K122305, K130128, K130343, K131647) and Trinity PLUS (K17255) · Dual mobility - Trinity Dual Mobility (K170359) and MobiliT (K191831)

· Bipolar - Bipolar-i (K183114)

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.

Indications for Use Comparison

The Icona Hip Stem is substantially equivalent to Actis DuoFix Hip Prosthesis (K150862), TriFit CF Hip Stem (K173880), Metafix Hip Stem (K082525, K121439, K15381, K212069) OMN MOD Hip Stem (K00788, K201657) in terms of intended use and indications, with the exception of OMNI MOD Hip Stem which is also indicated for revision.

Technological Comparison

The Icona Hip Stem is substantially equivalent to predicate device Actis DuoFix Hip Prosthesis (K150862) in terms of material (titanium alloy - Ti6Al4V), triple-taper geometry, collar design and stem sizes.

The Icona Hip Stem is substantially equivalent to predicate device TriFit CF (K173880) in terms of material (titanium alloy - Ti6Al4V), coating, taper design and neck geometry.

The Icona Hip Stem is substantially equivalent to previously cleared predicate device OMN MOD Hip System (K000788, K201657) in terms of material (titanium alloy - Ti6Al4V), neck geometry and finish.

The Icona Hip Stem is substantially equivalent to previously cleared predicate device MetaFix Hip Stem (K082525, K121439, K153381, K212069) in terms of intended use, indications, material (titanium alloy - Ti6Al4V), neck geometry, taper design and packaging.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807,92(b)

Non-clinical testing and rationales provided to support substantial equivalence include:

Distal stem fatique testing (ISO 7206-4)
Neck fatique testing (ISO 7206-6)
Cadaveric evaluation
Range of motion (ROM) (ISO 21535)
Impingement performance engineering rationale
Femoral head disassembly and corrosion performance engineering rationale

No clinical tests were performed to support the safety and effectiveness of the subject device

The results of the specific mechanical the lcona Hip Stem show that the device is substantially equivalent to the predicate devices. A comparison of indications for use also demonstrated substantial equivalence.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
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.(b)
Classification. Class II.