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 . (CDI-I)

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 (TiAL6V4) 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 Corin Metafix Hip Stern is available in 10 sizes marked 1 through 10. Each size is available in three offsets, including Standard (1359), Lateralized, (135°), and Standard (125°) apart from the size 1 which is available in two offsets, Standard (135°) and Lateralized (135°).

The Corin Metafix Hip Stem was originally cleared in K082525, K120362 & K121439. The purpose of this submission is to modify the labeling to include additional contraindications for the Metafix stem when used for hemi arthroplasty, for clarity to ensure safe or effective use. The indications and components for use with the Corin Metafix stem subject of this submission are identical to that of the predicate devices K082525, K120362 & K121439.

AI/ML Overview

The provided document describes a medical device, the Corin Metafix Hip Stem, and its regulatory submission (K130634). However, this document does NOT contain information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, or human reader effectiveness with AI assistance.

This submission is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving the device meets specific performance criteria through new studies.

Here's how the requested information relates to the provided text:

Table of acceptance criteria and reported device performance: Not provided. The document states "Non-Clinical Testing: A comparison of indications for use and contraindications demonstrate substantial equivalence" and "Clinical Testing: Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Hip Stem with modified labeling to the predicate devices." This indicates that no new performance data was generated for this specific submission to meet acceptance criteria.
Sample size used for the test set and data provenance: Not applicable. No new test set or clinical study was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set or ground truth was established.
Adjudication method for the test set: Not applicable. No new test set or adjudication was performed.
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 hip implant, not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. See point 5.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No new ground truth was established.
The sample size for the training set: Not applicable. No new training set was involved in this 510(k) submission.
How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary (K130634) for the Corin Metafix Hip Stem is a regulatory document asserting substantial equivalence to existing devices. It explicitly states that "Clinical testing was not necessary to determine substantial equivalence." Therefore, it does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth, or AI-related metrics.

Summary

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K130634 page 1 of 3

MAY 2 4 2013

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3. 510(K) SUMMARY
1. Applicant/Sponsor:	Corin USA10500 University Center DriveSuite 190Tampa, Florida 33612Establishment Registration No.: 1056629
2. Contact Person:	Lucinda Gerber, BA (Hons)Regulatory Affairs AssociateCorin USA813-977-4469lucinda.gerber@coringroup.comKathy TrierVP Clinical & Regulatory AffairsCorin USA813-977-4469kathy.trier@coringroup.com
3. Date:	March 08, 2013
4. Proprietary Name:	Corin Metafix Hip Stem
5. Common Name:	Hip Prosthesis
6. Product Codes:	LZO, KWL, KWY, JDI
7. Classification Name:	Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis (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)Hip joint metal/polymer semi-constrained cemented prosthesis.(21CFR 888.3350)

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K130634 page 2 of 3

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

·Corin Metafix Hip Stem (K082525) .
Corin Metafix Femoral Stem for Hemi-Arthroplasty (K120362)
Corin Metafix I-lip Stem (K121439) .
DePuy Orthopaedics Corail AMT Hip System (K042992) .

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:

. 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 . (CDI-I)

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

11. Summary of Technologies/Substantial Equivalence:

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The Metafix Hip Stem subject of this submission is identical to the predicates Metafix Hip Stems (K082525, K120362 & K121439) in intended use/indications for use, design, materials and sizes and similar in terms of contraindications. It is similar to the predicate DePuy Orthopaedics Corail AMT Hip System (K042992) in terms of intended use/indications for use, contraindications, and is identical in terms of material and coating. Based on these similarities, Corin believes that the Metafix Hip Stem is substantially equivalent to the predicate devices.

12. Non-Clinical Testing:

A comparison of indications for use and contraindications demonstrate substantial equivalence

13. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Hip Stem with modified labeling to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 24, 2013

Corin USA % Ms. Lucinda Gerber Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607

Re: K130634

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, KWY, KWL, JDI Dated: April 3, 2013 Received: April 4. 2013

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

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Page 2 - Ms. Lucinda Gerber

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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 yours,

ErinF.D.Keith

For

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

Enclosure

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2. INDICATIONS FOR USE

510(k) Number (if known): _ K130634_

Device Name: Corin Metafix Hip 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-arthroplasty femoral heads, as a hemi-arthroplasty, include:

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

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)

Elizabeth L. Frank -S.

Page 1 of 1

Division of Orthopedic Devices

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.