The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is intended for cementless use only.

Device Description

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL,V ) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-03(2009). The stem is indicated for use with Corin CoCr modular femoral heads and ceramic modular femoral heads with a 12/14 taper. (NOTE : the ceramic modular heads are not subject of this 510(k) submission.) The stem is available in nine sizes, each available in three offsets including standard (135°), lateralized 135°, and standard (125°).

The Corin Bipolar Head (K925897) is comprised of an outer CoCr shell, an inner liner of ultra high molecular weight polyethylene (UHMWPE), and an inner CoCr head. The Bipolar head is available in a range of outer diameter sizes and a variety of head offsets and is compatible with all Corin 12/14 taper femoral stems. The Corin Optimom Modular Head (K111911) is a polished, truncated CoCr alloy sphere with a high tolerance internal female taper and is available in a range of diameters with a variety of offsets. It is compatible with Corin 12/14 taper titanium and stainless steel femoral stems. The Bipolar and the Optimom Modular Heads are indicated for hip hemi-arthroplasty.

The purpose of this submission is to modify the labeling for the Metafix Femoral Hip Stem to include hip hemi-arthroplasty to the indications for use when the stem is mated with a Corin CoCr hemi-arthroplasty femoral head.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Corin Metafix Femoral Stem for Hemi-arthroplasty. This document is a regulatory submission for pre-market clearance, not a study evaluating device performance against acceptance criteria in the way a clinical trial would.

Here's an analysis based on the information provided, specifically addressing why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is typically found in a clinical study report or a design verification/validation report, neither of which is present in the provided 510(k) summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study.

The document states:

"A comparison of design, materials, size range, and indications for use demonstrate substantial equivalence with the predicate components."
"Testing was submitted in the predicate 510(k) submissions and as demonstrated in the substantial equivalence table, the Metafix Femoral Stem, when coupled with the Corin hip hemi-arthroplasty heads is substantially equivalent to the predicate devices and expected to be safe and effective for the proposed indications."

Therefore, there are no specific performance acceptance criteria or reported device performance metrics in this document. The "performance" is implicitly tied to the established performance of the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No "test set" in the context of a clinical study or performance evaluation is discussed. The submission relies on equivalence to predicate devices, which would have had their own historical data, but that data is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described as there is no test set in the context of this submission.

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 prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This device is a physical hip prosthesis, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No specific ground truth determination process is described for the device itself. The established safety and effectiveness of the predicate devices serve as the "ground truth" for the equivalence claim.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study (as described in the document):

The document describes a Substantial Equivalence Study documented in a 510(k) premarket notification (K120362).

Study Goal: To demonstrate that the Corin Metafix Femoral Stem for Hemi-arthroplasty is substantially equivalent to legally marketed predicate devices, particularly for an expanded indication for hip hemi-arthroplasty.
Methodology:
- Comparison to Predicate Devices: The Metafix Femoral Stem (K082525), Corin Optimom Modular Heads (K111911), and Corin Bipolar Heads (K925897) were identified as predicate devices.
- Basis of Equivalence: The submission argues that the Corin Metafix Hip Stem, when used for hemi-arthroplasty with compatible Corin CoCr hemi-arthroplasty femoral heads, is substantially equivalent based on:
  - Identical Intended Use/Indications for Use (for the heads): The Optimom and Bipolar heads are identical to predicate femoral heads in these aspects.
  - Identical Design, Materials, and Sizes: For the Metafix Femoral Stem, it is identical to the previously cleared Metafix Femoral Stem (K082525) in materials and sizes. The subject of the submission is a modification of Indications for Use.
  - Similar Components: The inner 26mm Eurocone CoCr femoral head of the Corin Bipolar Head is manufactured of the same material, is similar in design, and is within the range of previously indicated compatible components for the Metafix Femoral Stem.
- Non-Clinical Testing: The document states, "Testing was submitted in the predicate 510(k) submissions." This implies that the current submission relies on the non-clinical testing performed for the predicate devices to support the equivalence claim, rather than presenting new non-clinical tests for the modified indication. This non-clinical data would have included mechanical testing, material characterization, etc.
- Clinical Testing: The document explicitly states, "Clinical testing was not necessary to determine substantial equivalence between the Metafix Femoral Stem for total hip arthroplasty and the Metafix Femoral Stem for Hemi-arthroplasty." This indicates that no new clinical study was conducted for this specific submission to demonstrate performance.

In essence, the "study" is a regulatory comparison against existing, cleared devices, rather than a de novo performance study against defined acceptance criteria.

Summary

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MAY - 4 2012

3. 510(K) SUMMARY
1. Applicant/Sponsor:	Corin USA
	10500 University Center Drive
	Suite 190
	Tampa, Florida 33612
	Establishment Registration No.: 1056629
2. Contact Person:	Lucinda Gerber, BA (Hons)
	Regulatory Affairs Associate
	Corin USA
	813-977-4469
	lucinda.gerber@coringroup.com
3. Date:	February 3, 2012
4. Proprietary Name:	Metafix Femoral Stem for Hemi-arthroplasty
5. Common Name:	Hip Prosthesis
6. Product Codes:	LZO, KWL, KWY
7. Classification Name:	Hip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis (21CFR 888.3390)
	Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis (21CFR 888.3360)
	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21CFR 888.3353)
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
	•	Corin Metafix Femoral Stem (K082525)
	•	Corin Optimom Modular Heads (K111911)
	•	Corin Bipolar Heads (K925897)
	•	Taper Fit Total Hip System (K003666)

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9. Device Description:

10. Intended Use / Indications:

The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

매 Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur

트 Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) The Corin Metafix Hip Stem is intended for cementless use only.

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11. Summary of Technologies/Substantial Equivalence:

The Corin Optimom Modular heads and the Corin Bipolar heads are identical to the predicate femoral heads in intended use/indications for use, design, materials and sizes. The Corin Metafix Femoral Stem for Hemi-arthroplasty is identical to the Metafix Femoral Stem cleared in K082525 in materials and sizes. The subject of this submission, Metafix Femoral Stem for Hemi-arthroplasty, is for a modification of the indications for use to include hip hemiarthroplasty with the addition of compatible components. The inner 26mm Eurocone CoCr femoral head of the Corin Bipolar Head (K925897, K003666), is manufactured of the same material, is similar in design and within the range of the 22mm and 28mm Eurocone CoCr modular heads that were previously indicated as compatible components for use with the Metafix Femoral Stem (K082525). The Optimom Modular head is indicated for use with the Metafix Hip Stem and the Bipolar Head is indicated with any Corin 12/14 taper hip stem.

12. Non-Clinical Testing:

A comparison of design, materials, size range, and indications for use demonstrate substantial equivalence with the predicate components. Testing was submitted in the predicate 510(k) submissions and as demonstrated in the substantial equivalence table, the Metafix Femoral Stem, when coupled with the Corin hip hemi-arthroplasty heads is substantially equivalent to the predicate devices and expected to be safe and effective for the proposed indications.

13. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Metafix Femoral Stem for total hip arthroplasty and the Metafix Femoral Stem for Hemi-arthroplasty.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with flowing lines representing movement or energy.

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

Corin U.S.A. % Ms. Lucinda Gerber 10500 University Center Drive Suite 190 Tampa, FL 33612

MAY - 4 2012

Re: K120362

Trade/Device Name: Metafix Femoral Stem for Hemi-Arthroplasty Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: II Product Code: LZO, KWL. KWY Dated: February 3, 2012 Received: February 6, 2012

Dear Ms. Gerber:

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 Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Lucinda Gerber

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

y yours,

Melkerson

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

Enclosure

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2. INDICATIONS FOR USE

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Device Name: Corin Metafix Femoral Stem

Indications for Use:

The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-atthroplasty femoral heads, as a hemi-arthroplasty, include:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular 0 necrosis
Rheumatoid arthritis o
Correction of functional deformity ೦
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur 0
Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH) O

The Corin Metafix Hip Stem is indicated for cementless use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF · NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K120362

Page 5 of 141

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.