CORAIL Cemented Femoral Stem

• K Number: K231526
• Device Name: CORAIL Cemented Femoral Stem
• Manufacturer: DePuy Ireland UC
• Date Cleared: 2023-12-19 ( 207 days)
• Product Code: KWY , KWL , LZO
• Regulation Number: 888.3390
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K123991 , K220216
• Predicate For: N/A

Intended Use

The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Avascular necrosis of the femoral head.
3. Non-union of femoral neck fractures.
4. Certain high subcapital and femoral neck fractures in the elderly.
5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

The DePuy CORAIL Cemented Femoral Stems are indicated only for use with bone cement.

Device Description

The CORAIL Cemented Femoral Stem is manufactured from wrought high nitrogen stainless steel, and is designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty. The CORAIL Cemented Femoral Stem implants are uncoated with a polished finish, intended for use with bone cement. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for a wide range of patients. The CORAIL Cemented Femoral Stem is designed to provide a cemented version of the primary predicate DePuy CORAIL AMT Hip Prosthesis stem (cleared under 510(k) K123991).

AI/ML Overview

This FDA 510(k) summary describes a new device, the CORAIL Cemented Femoral Stem, and its comparison to predicate devices, but it does not include any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "No clinical tests were conducted to demonstrate substantial equivalence." (Page 10)
• The non-clinical tests were conducted "to demonstrate its substantial equivalence of safety and effectivenes to the identified predicate devices." (Page 10)

The "acceptance criteria" presented in the document are primarily the technological characteristics of the device being compared to predicate devices to establish substantial equivalence, rather than performance metrics with specific targets. The "study" mentioned consists of a series of non-clinical tests (mechanical, material, sterilization, biocompatibility, etc.) designed to show that the new device is as safe and effective as the predicate devices, not that it meets specific, predefined performance thresholds against a gold standard in a clinical context.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This detailed information is not included. The document compares features of the new device to predicates as shown in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES" (pages 6-9), but these are comparisons of design and material, not performance against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study with a test set is described. Non-clinical tests typically use material samples or prototypes, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set requiring expert ground truth.
4. Adjudication method for the test set: Not applicable as there is no clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical hip stem, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip stem.
7. The type of ground truth used: Not applicable as there is no clinical test set requiring ground truth.
8. The sample size for the training set: Not applicable as there is no machine learning component or training set discussed.
9. How the ground truth for the training set was established: Not applicable as there is no machine learning component or training set discussed.

Summary of Non-Clinical Tests Conducted (relevant to the "study" aspect as provided):

The document lists the following non-clinical tests to demonstrate substantial equivalence:

• Distal fatigue and neck fatigue: performed per ISO 7206-4:2010, ISO 7206:2013 and ASTM F2068-3.
• Range of motion: performed per EN ISO 21535:2009+A1:2016.
• MRI Safety: performed per ASTM F2503-23, ASTM F2182-19e2, ASTM F2052-21, ASTM F2213-17 and ASTM F2119-07.
• Biocompatibility testing: performed per EN ISO 10993-1-2018, ISO 10993-3:2014, ISO 1099-5:2009, ISO 1099-6:2016, ISO 1099-10:2010, ISO 10993-11:2017, ISO 10993-12:2012, ISO 10993-18:2020, BS EN ISO 22442-1:2015 and ISO 10993-17:2002.
• Bacterial endotoxins: performed per ANSI/AAMI ST 72:2019.

The conclusion from these non-clinical tests was that "The CORALL Cemented Femoral Stem is substantialy equivalent to the identified predicates with respect to minded use, indications, materials, geometry, range of sizes, and method of fixation. Results of performance that the CORAL Cemented Femoral Stem performs as well as the predicate devices DePuy CORAIL AMT Hip Prosthesis and C-STEM AMT LE Prosthesis (K123991 and K220216)." (Page 10)

Summary

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December 19, 2023

DePuy Ireland UC Nicola Keedy Regulatory Affairs Director Loughbeg, Ringaskiddy Co. Cork Ireland

Re: K231526

Trade/Device Name: CORAIL Cemented Femoral Stem Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY, KWL, LZO Dated: May 26, 2023 Received: December 8, 2023

Dear Nicola Keedy:

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.

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"

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(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 (QS) 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 OS 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.

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 mediation-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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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

Submission Number (if known)

K231526

Device Name

CORAIL Cemented Femoral Stem

Indications for Use (Describe)

The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

• 2. Avascular necrosis of the femoral head.
• 3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,

hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Partial hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.

2. Avascular necrosis of the femoral head.

• 3. Non-union of femoral neck fractures.
• 4. Certain high subcapital and femoral neck fractures in the elderly.

5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.

6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

The DePuy CORAIL Cemented Femoral Stems are indicated only for use with bone cement.

Type of Use (Select one or both, as applicable)

< | Prescription Use (Part 21 CFR 801 Subpart D)

Counter Use (21 CFR 801 Subpart C)

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K231526 Page 1 of 1

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510(k) Summary

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg, RingaskiddyCo. Cork, IRELAND
Establishment RegistrationNumber	3015516266
Name of contact person	Amy Joyce
e-mail address	[e-mail]
Alternative contact person	Nicola Keedy
e-mail address	[e-mail]
Work mobile	[phone] (UK time zone)
Date prepared	26th May 2023
Name of device
Trade or proprietary name	CORAIL Cemented Femoral Stem
Common or usual name	Hip Stem
Classification name	Hip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis.Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3390, 888.3360, 888.3353
Product Code(s)	KWY, KWL, LZO
Legally marketed device(s) towhich equivalence is claimed	Primary predicate - DePuy CORAIL AMT Hip Prosthesis K123991, clearedSeptember 16, 2013Secondary predicate – C-STEM AMT LE Prosthesis K220216, cleared July22, 2022
Reason for 510(k) submission	The purpose of this 510K submission is to obtain market clearance for theCORAIL Cemented Femoral Stem
Device description	The CORAIL Cemented Femoral Stem is manufactured from wrought highnitrogen stainless steel, and is designed to be used as one component of a
	system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty. The CORAIL Cemented Femoral Stem implants are uncoated with a polished finish, intended for use with bone cement. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for a wide range of patients. The CORAIL Cemented Femoral Stem is designed to provide a cemented version of the primary predicate DePuy CORAIL AMT Hip Prosthesis stem (cleared under 510(k) K123991).
Intended use of the device	Total hip arthroplasty and hemi-hip arthroplasty
Indications for use	The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Avascular necrosis of the femoral head. 3. Non-union of femoral neck fractures. 4. Certain high subcapital and femoral neck fractures in the elderly. 5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty. The CORAIL Cemented Femoral Stems are indicated only for use with bone cement.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
Characteristics	Subject Device:CORAIL CementedFemoral Stem	Primary Predicate Device:DePuy CORAIL AMT Hip ProsthesisK123991	Secondary Predicate Device:C-STEM AMT LE ProsthesisK220216
IntendedUse andIndicationsfor Use	The subject device hasthe same intended use asprimary predicateK123991.The subject device isindicated for total andhemi hip arthroplasty,same as primarypredicate K123991, andindicated for cementeduse, same as secondarypredicate K220216.	Intended for use in total hip arthroplasty and hemi-hip arthroplasty.Total hip replacement or hip arthroplasty is indicated in the following conditions:1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,rheumatoid arthritis, or congenital hip dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery including joint reconstruction, internal fixation,arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hipreplacement.5.Certain cases of ankylosis.Partial hip arthroplasty or hip hemi-arthroplasty is indicated in the followingconditions:1. Acute fracture of the femoral head or neck that cannot be appropriately reducedand treated with internal fixation.2. Avascular necrosis of the femoral head.3. Non-union of femoral neck fractures.4. Certain high subcapital and femoral neck fractures in the elderly.5. Degenerative arthritis involving only the femoral head in which the acetabulumdoes not require replacement.6. Pathology involving only the femoral head/neck and/or proximal femur thatcan be adequately treated by hip hemi-arthroplasty.HA coated stems of the CORAIL Hip System are indicated for cementless useonly.	Intended for use in total hiparthroplasty.Total hip replacement is indicated inthe following conditions:1. A severely painful and/or disabledjoint from osteoarthritis, traumaticarthritis, rheumatoid arthritis, orcongenital hip dysplasia.2. Avascular necrosis of the femoralhead.3. Acute traumatic fracture of thefemoral head or neck.4. Failed previous hip surgeryincluding joint reconstruction,internal fixation, arthrodesis,hemiarthroplasty, surfacereplacement arthroplasty, or total hipreplacement.5. Certain cases of ankylosis.The C-STEM AMT Hip Prosthesis isindicated for cemented use only.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
Characteristics	Subject Device:CORAIL CementedFemoral Stem	Primary Predicate Device:DePuy CORAIL AMT Hip ProsthesisK123991	Secondary Predicate Device:C-STEM AMT LE ProsthesisK220216
Material	The subject device usesthe same materials tosecondary predicatedevices K220216	Forged titanium alloy Ti-6Al-4V, plasma-sprayed with a biocompatiblehydroxyapatite (HA) coating for bone fixation	Wrought high nitrogen stainlesssteel, conforming to ISO 5832-9.
Fixation	The subject device usesthe same method offixation as the secondarypredicate devicesK220216	Press Fit; Cementless	Cemented
Stem Size	The subject device hasan identical size range toa sub-set of the sizerange of primarypredicate K123991devices	Cementless Collared 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20Cementless Collarless 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20Cementless LAT Collared 9, 10, 11, 12, 13, 14, 15, 16, 18, 20Cementless HO Collarless 9, 10, 11, 12, 13, 14, 15, 16, 18, 20	CDH ("00"), 1A, 2A, 3A, 2 LongSO, 2 Long HO, 3 Long SO, 3 LongHO, 3XL205, 3 XL240
StemOffset	The subject device hasthe same stem offsetoptions as the primarypredicate K123991	Standard, High	Same as primary predicate

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
Characteristics	Subject Device:CORAIL CementedFemoral Stem	Primary Predicate Device:DePuy CORAIL AMT Hip ProsthesisK123991	Secondary Predicate Device:C-STEM AMT LE ProsthesisK220216
Collar	The subject device iscollarless, same assecondary predicatedevices K220216, and asubset of the primarypredicate devicesK123991	Collared & Collarless	Collarless
SterileMethod	The subject device hasthe same sterile methodas both primary predicateK123991, and secondarypredicate K220216.	Gamma irradiation	Same as primary predicate
SAL	The subject device hasthe same SAL as primarypredicate K123991, andsecondary predicateK220216.	10-6	Same as primary predicate
Packaging	The subject has the samepackaging format as bothprimary predicateK123991, and secondarypredicate K220216.	Double Sterile Barrier PackINNER: Nylon PouchOUTER: PETG Blister, Tyvek Lid	Same as primary predicate

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
Characteristics	Subject Device:CORAIL CementedFemoral Stem	Primary Predicate Device:DePuy CORAIL AMT Hip ProsthesisK123991	Secondary Predicate Device:C-STEM AMT LE ProsthesisK220216
Shelf Life	The subject device hasthe same shelf-life asboth primary predicateK123991, and secondarypredicate K220216.	5 years	5 years

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The subject device [CORAIL Cemented Femoral Stem] has the collarless subset of the primary predicate device [DePuy CORAIL AMT Hip Prosthesis (K123991) and in common with the secondary predicate (C-STEM AMT LE Prosther finish is uncoated and brighty polished, and the material of construction is wrought Stainless Steel.

The subject device has the same intended use as the method of sterlization. Sterlity Assurance Level (SAL) and claimed shelf-life are the same across the subject and both predicate devices. The same as for the same as for the secondary predicate device.

The subject device is indicated for total and heminary predicate, and is indicated for cemented use, same as the secondary predicate. The range of stem sizes and neck offsets available are identical for the subject device and a subset of the primary predicate.

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The CORAIL Cemented Femoral Stem was tested to demonstrate its substantial equivalence of safety and effectivenes to the identified predicate devices. Testing and analyses included:

• Distal fatigue and neck fatigue per ISO 7206-4:2010, ISO 7206:2013 and ASTM F2068-3 ●
• Range of motion per EN ISO 21535:2009+A1:2016 ●
• MRI Safety per ASTM F2503-23, ASTM F2182 -19e2, ASTM F2052-21, ASTM F2213-17 and ASTM F2119-07 .
• Biocompatibility testing per EN ISO 10993-1-2018, ISO 10993-3:2014, ISO 1099-5:2009, ISO 1099-6:2016, ISO 1099-10:2010, ISO ● 10993-11:2017, ISO 10993-12:2012, ISO 10993-18:2020, BS EN ISO 22442-1:2015 and ISO 10993-17:2002
• Bacterial endotoxins per ANSI/AAMI ST 72:2019 ●

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The CORALL Cemented Femoral Stem is substantialy equivalent to the identified predicates with respect to minded use, indications, materials, geometry, range of sizes, and method of fixation. Results of performance that the CORAL Cemented Femoral Stem performs as well as the predicate devices DePuy CORAIL AMT Hip Prosthesis and C-STEM AMT LE Prosthesis (K123991 and K220216).

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.