Who is the manufacturer of CORAIL Cemented Femoral Stem?

Depuy Ireland UC filed the 510(k) submission for CORAIL Cemented Femoral Stem (K231526).

What is the FDA product code for CORAIL Cemented Femoral Stem?

KWY. It is classified under 21 CFR 888.3390 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for CORAIL Cemented Femoral Stem?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CORAIL Cemented Femoral Stem?

DePuy CORAIL AMT Hip Prosthesis (K123991); C-STEM AMT LE Prosthesis (K220216).

Who can help prepare an FDA 510(k) submission like CORAIL Cemented Femoral Stem?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CORAIL Cemented Femoral Stem

K231526 · Depuy Ireland UC · KWY · Dec 19, 2023 · Orthopedic

Device Facts

Record ID	K231526
Device Name	CORAIL Cemented Femoral Stem
Applicant	Depuy Ireland UC
Product Code	KWY · Orthopedic
Decision Date	Dec 19, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3390
Device Class	Class 2
Attributes	Therapeutic

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 Story

CORAIL Cemented Femoral Stem is a metallic hip prosthesis component for total or hemi-hip arthroplasty. Device is implanted by orthopedic surgeons in a clinical/OR setting. It serves as a cemented version of the CORAIL AMT stem; provides structural support for the femoral head/neck. Input is the patient's anatomical requirements; device provides a range of stem sizes and neck offsets to match patient anatomy. Output is a stable femoral component fixed with bone cement. Benefits include restoration of joint function and pain relief in patients with degenerative or traumatic hip pathology.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including distal/neck fatigue (ISO 7206), range of motion (ISO 21535), MRI safety (ASTM F2503, F2182, F2052, F2213, F2119), biocompatibility (ISO 10993), and bacterial endotoxin testing.

Technological Characteristics

Wrought high nitrogen stainless steel femoral stem; collarless; polished finish; cemented fixation. Sterilized via gamma irradiation (SAL 10^-6). Complies with ISO 5832-9 (material), ISO 7206 (fatigue), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for total and hemi hip replacement in patients with painful/disabled joints due to osteoarthritis, traumatic/rheumatoid arthritis, congenital dysplasia, avascular necrosis, acute femoral head/neck fractures, failed previous hip surgeries, or ankylosis. Indicated for use only with bone cement.

Regulatory Classification

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.

Predicate Devices

DePuy CORAIL AMT Hip Prosthesis (K123991)
C-STEM AMT LE Prosthesis (K220216)

Related Devices

K983226 — OSTEONICS X CEMENTED HIP STEM SERIES · Osteonics Corp. · Dec 4, 1998
K962448 — PRIMALOC CEMENTED HIP SYSTEM · Ortho Development Corp. · Sep 19, 1996
K211657 — EMPHASYS Femoral Stems · Depuy Ireland UC · Aug 5, 2021
K131952 — CORIN METAFIX HIP STEM · Corin USA · Dec 16, 2013
K181340 — Cemented TSI Hip Stem · Signature Orthopaedics Pty, Ltd. · Feb 11, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. 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" {1}------------------------------------------------ (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ 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}------------------------------------------------ ### 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) ### 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." K231526 Page 1 of 1 {4}------------------------------------------------ # 510(k) Summary | Submitter Information | | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | DePuy Ireland UC | | Address | Loughbeg, Ringaskiddy Co. Cork, IRELAND | | Establishment Registration Number | 3015516266 | | Name of contact person | Amy Joyce | | e-mail address | AJoyce1@its.jnj.com DePuySynthesJointsRegulatoryAffairs@its.jnj.com | | Alternative contact person | Nicola Keedy | | e-mail address | NKeedy@its.jnj.com | | Work mobile | +44 7824320636 (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 uncemented prosthesis. Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented 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) to which equivalence is claimed | Primary predicate - DePuy CORAIL AMT Hip Prosthesis K123991, cleared September 16, 2013 Secondary predicate – C-STEM AMT LE Prosthesis K220216, cleared July 22, 2022 | | Reason for 510(k) submission | The purpose of this 510K submission is to obtain market clearance for the CORAIL Cemented Femoral Stem | | 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). | | 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. | {5}------------------------------------------------ {6}------------------------------------------------ | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES | | | | |----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteri stics | Subject Device: CORAIL Cemented Femoral Stem | Primary Predicate Device: DePuy CORAIL AMT Hip Prosthesis K123991 | Secondary Predicate Device: C-STEM AMT LE Prosthesis K220216 | | Intended Use and Indications for Use | The subject device has the same intended use as primary predicate K123991. The subject device is indicated for total and hemi hip arthroplasty, same as primary predicate K123991, and indicated for cemented use, same as secondary predicate 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 hip replacement. 5.Certain cases of ankylosis. Partial hip arthroplasty 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 hemi-arthroplasty. HA coated stems of the CORAIL Hip System are indicated for cementless use only. | Intended for use in total hip arthroplasty. 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. The C-STEM AMT Hip Prosthesis is indicated for cemented use only. | | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES | | | | | Characteri stics | Subject Device: CORAIL Cemented Femoral Stem | Primary Predicate Device: DePuy CORAIL AMT Hip Prosthesis K123991 | Secondary Predicate Device: C-STEM AMT LE Prosthesis K220216 | | Material | The subject device uses the same materials to secondary predicate devices K220216 | Forged titanium alloy Ti-6Al-4V, plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation | Wrought high nitrogen stainless steel, conforming to ISO 5832-9. | | Fixation | The subject device uses the same method of fixation as the secondary predicate devices K220216 | Press Fit; Cementless | Cemented | | Stem Size | The subject device has an identical size range to a sub-set of the size range of primary predicate K123991 devices | Cementless Collared 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20 Cementless Collarless 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20 Cementless LAT Collared 9, 10, 11, 12, 13, 14, 15, 16, 18, 20 Cementless HO Collarless 9, 10, 11, 12, 13, 14, 15, 16, 18, 20 | CDH ("00"), 1A, 2A, 3A, 2 Long SO, 2 Long HO, 3 Long SO, 3 Long HO, 3XL205, 3 XL240 | | Stem Offset | The subject device has the same stem offset options as the primary predicate K123991 | Standard, High | Same as primary predicate | {7}------------------------------------------------ {8}------------------------------------------------ | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES | | | | |----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Characteri stics | Subject Device: CORAIL Cemented Femoral Stem | Primary Predicate Device: DePuy CORAIL AMT Hip Prosthesis K123991 | Secondary Predicate Device: C-STEM AMT LE Prosthesis K220216 | | Collar | The subject device is collarless, same as secondary predicate devices K220216, and a subset of the primary predicate devices K123991 | Collared & Collarless | Collarless | | Sterile Method | The subject device has the same sterile method as both primary predicate K123991, and secondary predicate K220216. | Gamma irradiation | Same as primary predicate | | SAL | The subject device has the same SAL as primary predicate K123991, and secondary predicate K220216. | 10-6 | Same as primary predicate | | Packaging | The subject has the same packaging format as both primary predicate K123991, and secondary predicate K220216. | Double Sterile Barrier Pack INNER: Nylon Pouch OUTER: PETG Blister, Tyvek Lid | Same as primary predicate | {9}------------------------------------------------ | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES | | | | |----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------| | Characteri stics | Subject Device: CORAIL Cemented Femoral Stem | Primary Predicate Device: DePuy CORAIL AMT Hip Prosthesis K123991 | Secondary Predicate Device: C-STEM AMT LE Prosthesis K220216 | | Shelf Life | The subject device has the same shelf-life as both primary predicate K123991, and secondary predicate K220216. | 5 years | 5 years | {10}------------------------------------------------ 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).