The TaperFit Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar revision. Prosthesis hemi-arthroplasty femoral heads.

The TaperFit Hip Stem is indicated for cemented, single use only.

Device Description

The TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone (E100.XXX cleared in K003666) and Trinity CoCrMo modular femoral heads (E321.XXX cleared in K093472, K110087, K122305, K123705, K130128, K130343 and K131647). The stem is available in sizes, 0 through 4 with 3 offsets 50mm, 45mm, and 38mm, as well as a CDH option with a 36mm offset.

The TaperFit Hip Stem was originally cleared in K142761. This submission is being made to modify the indications for use to include hemi-arthroplasty when used with previously cleared Corin hemi-arthroplasty femoral heads as compatible components. The Corin CoCr Modular 26mm heads (E100.X26) have been cleared as compatible components of the Taper-Fit Hip stem (K003666). The Corin CoCr Modular 26mm heads (E100.X26) are part of the construct of the bipolar heads. Included in this submission is the Corin Bipolar Femoral Head (K925897) as a compatible component, which is indicated for hemi-arthroplasty.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "TaperFit Hip Stem". It's a regulatory submission to the FDA, not a study evaluating device performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information (acceptance criteria, sample sizes for test/training sets, expert qualifications, etc.) is not present in this document because it pertains to a different type of evaluation.

Here's a breakdown of the information that is available or can be inferred, and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Absent. This document does not present a table of acceptance criteria or report specific performance metrics for the device. It refers to non-clinical testing data from previous submissions for establishing substantial equivalence.

2. Sample size used for the test set and the data provenance

Absent. This document does not describe a "test set" in the context of an AI/algorithm performance evaluation. The "non-clinical testing" mentioned involved mechanical and fatigue testing, not a data-driven test set with human-equivalent performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Absent. Not applicable to this type of regulatory submission. The ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images or data.

4. Adjudication method for the test set

Absent. Not applicable.

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

Absent. This is a hardware device (hip stem), not an AI algorithm. Therefore, MRMC studies and AI-assisted reading are not relevant.

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

Absent. This is a hardware device, not an algorithm.

7. The type of ground truth used

For the non-clinical testing mentioned, the "ground truth" would be engineering standards, material specifications (e.g., ISO 5832-9 for stainless steel), and the results of mechanical fatigue, static, rotational torque, and fretting/corrosion tests.

8. The sample size for the training set

Absent. Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Absent. Not applicable.

Summary of available information related to the device and its evaluation (from the document):

Device Name: TaperFit Hip Stem
Type of Device: Hip joint metal/polymer semi-constrained cemented prosthesis
Indications for Use: Relief of pain and restoration of hip function following femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis, and total hip revision. Also indicated for hemi-arthroplasty when used with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads. Indicated for cemented, single use only.
Predicate Devices:
- Corin TaperFit Hip Stem (K142761)
- Corin Taper-Fit Hip Stem (K992234, K003666)
Substantial Equivalence Claim: The TaperFit Hip Stem (subject of this submission) is claimed to be identical in design, materials, coating, and sizes to K142761, and similar in intended use/indications. It's also claimed to be identical in materials and coating, and similar in design, sizes, and intended use/indications to K992234 and K003666. The main modification in this submission is an expanded indication for use to include hemi-arthroplasty with compatible Corin hemi-arthroplasty femoral heads.
Non-Clinical Testing Mentioned: FEA (Finite Element Analysis), mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. These tests were performed and submitted in previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).
Clinical Testing: "Clinical testing was not necessary in this Traditional 510(k)."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2016

Corin USA Limited Ms. Diana L. Nader-Martone Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607

Re: K153725

Trade/Device Name: Taperfit Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, JDG, KWY Dated: December 23, 2015 Received: December 28, 2015

Dear Ms. Nader-Martone:

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 (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. 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.

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Diana L. Nader-Martone

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153725

Device Name TaperFit Hip Stem

Indications for Use (Describe)

The TaperFit Hip Stem is indicated for cemented, single 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)

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1. Applicant/Sponsor:Distributor	Corin USA5670 W. Cypress StreetSuite CTampa, Florida 33607Establishment Registration No.: 1056629
2. Contact Person:	Diana L. Nader-MartoneRegulatory Affairs AssociateCorin USA813-977-4469diana.nader-martone@coringroup.comKathy TrierVP Global Regulatory and Clinical AffairsCorin USA813-977-4469kathy.trier@coringroup.com
3. Date:	March 24, 2016
4. Proprietary Name:	TaperFit Hip Stem
5. Common Name:	Hip Prosthesis
6. Product Code(s):	JDI, JDG, KWY

7. Classification Name:

21CFR 888.3350 – Hip joint metal/polymer semi-constrained cemented prosthesis 21CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis 21CFR 888.3360 – Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis

8. Legally Marketed Devices to which Substantial Equivalence is claimed:

Corin TaperFit Hip Stem (K142761) ●
Corin Taper-Fit Hip Stem (K992234, K003666) .

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9. Device Description:

10. Intended Use / Indications:

The TaperFit Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip revision. The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads.

The TaperFit Hip Stem is indicated for cemented, single use only.

11. Summary of Technologies / Substantial Equivalence:

The TaperFit Hip Stem, subject of this submission, and the predicate TaperFit Hip Stem (K142761) are identical in design, materials, coating, and sizes and similar in terms of intended use/indications for use. Additionally, the TaperFit Hip Stem, subject of this submission, and the predicates, Taper-Fit Hip Stem (K992234 and K003666) are identical in materials, and coating, and similar in terms of design, sizes, and intended use/indications for use. Based on these similarities, Corin believes that the TaperFit Hip Stem is substantially equivalent to the predicate devices.

12. Non-Clinical Testing:

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Non-clinical testing and analysis included FEA, mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. This testing was performed and submitted in the previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).

13. Clinical Testing:

Clinical testing was not necessary in this Traditional 510(k).

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.