CORIN METAFIX FEMORAL STEM by CORIN USA

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
DDH/CDH
The Corin Metafix Hip Stem is indicated 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 (TiAI.V.) alloy for surgical implant applications, conforming to ASTM F136-2 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-88. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in 9 sizes (Size 2 to Size 10), each available in three lateral offsets including standard, lateralized, and Coxa Vara.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Corin Metafix Hip Stem, structured as requested. It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel device performance against specific, pre-defined acceptance criteria in the way a new drug or high-risk device might.

Acceptance Criteria and Study for Corin Metafix Hip Stem

This document describes a 510(k) submission for the Corin Metafix Hip Stem, asserting its substantial equivalence to a predicate device (Depuy Orthopaedics Corail AMT Hip System). The concept of "acceptance criteria" in this context is primarily focused on demonstrating that the new device performs at least as well as the predicate for its intended use, rather than meeting novel performance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance (Corin Metafix Hip Stem)
Mechanical Performance / Safety	Fatigue Strength: Device should withstand physiological loading conditions over its intended lifespan without fracture or failure, comparable to the predicate device.	Met Acceptance: Non-clinical testing included "mechanical fatigue testing." The results of this testing, along with static tensile testing and range of motion testing, "show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." Implicitly, its fatigue performance was found to be comparable and adequate.
	Static Tensile Strength: Device should withstand static tensile forces without deformation or failure, comparable to the predicate device.	Met Acceptance: "Static tensile testing" was performed. Results, along with fatigue and range of motion testing, "show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." Implicitly, its static tensile performance was found to be comparable and adequate.
	Range of Motion: Device allows for appropriate range of motion when implanted, comparable to the predicate device.	Met Acceptance: "Range of motion testing" was performed. Results, along with fatigue and static tensile testing, "show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." Implicitly, its range of motion performance was found to be comparable and adequate.
Biocompatibility / Material Safety	Material Conformance: Device materials (Titanium (TiAI.V.) alloy, Hydroxyapatite coating) must conform to established ASTM standards for surgical implant applications.	Met Acceptance: The stem is "manufactured from Titanium (TiAI.V.) alloy for surgical implant applications, conforming to ASTM F136-2" and is "coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-88." This directly indicates material conformance to the specified standards.
Functional / Design Equivalence	Proximal Horizontal Grooves, Distal Vertical Grooves, Medial Calcar Grooves: Presence and design of these features should be substantially equivalent to the predicate device to ensure comparable seating and stability.	Met Acceptance: The device "has proximal horizontal grooves, distal vertical grooves and medial calcar grooves that are substantially equivalent to those found on the predicate device, the Depuy Corail AMT Hip System." This explicitly states equivalence in these design features.
Indications for Use / Intended Use Equivalence	Matching Indications: The indications for use of the new device must be identical or substantially similar to the predicate device to justify substantial equivalence.	Met Acceptance: "The Corin Metafix Hip Stem has the same intended use and indications... as the predicate." The listed indications for both are: Non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union/femoral neck/trochanteric fractures, and DDH/CDH.
Manufacturing Processes (Implied for 510(k))	While not explicitly listed as an "acceptance criterion" in performance, implicit in a 510(k) is that the manufacturing process ensures consistent quality and adherence to specifications, which is typically demonstrated through a Quality Management System (QMS) as per 21 CFR Part 820.	Met Acceptance: The FDA's substantial equivalence letter reminds the applicant of their responsibility to "comply with all the Act's requirements, including... good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)." This indicates that the expectation is that they meet these unstated but critical criteria.
Clinical Performance (No Specific Criteria for SE)	For a 510(k), explicit prospective clinical performance criteria are typically not required if substantial equivalence can be demonstrated through non-clinical means and similarity to a predicate. The "acceptance criterion" is effectively "clinical testing is not necessary to prove substantial equivalence."	Met Acceptance: "Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Hip Stem and the predicate device." This implicitly means that based on the non-clinical data and design similarity, the device is presumed to have comparable clinical performance to the predicate.

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

Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of clinical data. The "test set" here refers to the specimens used for the non-clinical mechanical testing (fatigue, static tensile, range of motion). The exact number of hip stems tested for each mechanical evaluation is not provided in this summary.
Data Provenance: The mechanical testing described (fatigue, static tensile, range of motion) is non-clinical. The origin of the data is therefore laboratory-based testing performed by the manufacturer (Corin USA) or a contracted lab. It is prospective in the sense that the tests were conducted specifically for this submission. There is no mention of geographical provenance for the subjects being tested as it's not human data.

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

This information is not applicable as the "test set" described consists of non-clinical mechanical performance tests. Ground truth in this context would be the objective measurement of physical properties, not expert opinion.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" consists of non-clinical mechanical performance tests. No adjudication of expert opinions or interpretations was involved.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is common for AI/imaging devices involving human interpretation, but it is entirely irrelevant for a mechanical orthopedic implant like a hip stem.

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

No. A standalone algorithm performance study was not done. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical mechanical tests, the "ground truth" would be the objective, empirically measured physical properties of the device (e.g., force to fracture, cycles to failure, range of motion limits under load). This is based on established engineering principles and ASTM standards for materials and testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device being a mechanical implant. AI models have training sets, but this product does not involve AI.

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

This information is not applicable. As there is no "training set," there is no ground truth to establish for it.

Summary

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	3.	510(K) SUMMARY
1. Applicant/Sponsor:	Corin USA10500 University Center DriveSuite 190Tampa, Florida 33612Establishment Registration No.:
2. Contact Person:	Ashlea Bowen, RACRegulatory Affairs AssociateCorin USA813-977-4469ashlea.bowen@coringroup.com
3. Proprietary Name:	Corin Metafix Hip Stem
4. Common Name:	Femoral Hip Stem
5. Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21CFR 888.3353)Hip joint metal/polymer semi-constrained cemented prosthesis (21CFR 888.3350)
6. Product Code:	LZO, JDI
7. Legally Marketed Devices to which Substantial Equivalence is claimed:

a. Depuy Orthopaedics Corail AMT Hip System (K042992)

Device Description:

Intended Use / Indications:

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The indications for the Corin Metafix Hip Stem as a total hip arthroplasty include:

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

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

1. Summary of Technologies/Substantial Equivalence:
  The Corin Metafix Hip Stem has the same intended use and indications and is manufactured from the same materials as the predicate. Additionally, the Corin Metafix Hip Stem has proximal horizontal grooves, distal vertical grooves and medial calcar grooves that are substantially equivalent to those found on the predicate device, the Depuy Corail AMT Hip System. Based on these similarities, Corin believes that the Metafix Hip Stem is substantially equivalent to the predicate device.
1. Non-Clinical Testing:
  Non-clinical testing and analysis included mechanical fatigue testing, static tensile testing and range of motion testing. The results of this testing show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
1. Clinical Testing:
  Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Hip Stem and the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure with outstretched arms, symbolizing care and protection. The overall design is simple and conveys a sense of authority and service.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Corin USA % Ms. Ashlea Bowen, RAC Regulatory Affairs Associate 10500 University Center Drive Suite 190 Tampa, Florida 33612

FEB - 4 2010

Re: K082525

Trade/Device Name: Corin Metafix 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: LZO, JDI Dated: December 17, 2009 Received: December 18, 2009

Dear Ms. Bowen:

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

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Page 2 - Ms. Ashlea Bowen, RAC

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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Javarefneun

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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INDICATIONS FOR USE

510(k) Number (if known): __________

Device Name: Corin Metafix Femoral Stem

Indications for Use:

The indications for the Corin Metafix Hip Stem as a total hip arthroplasty include:

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

Duta for mxm

(Division Sign-Or Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K082525

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.